CN1215818C - Double layer hollow blood vessel internal support used for vascular anastomosis and its preparation method - Google Patents
Double layer hollow blood vessel internal support used for vascular anastomosis and its preparation method Download PDFInfo
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- CN1215818C CN1215818C CN 03148156 CN03148156A CN1215818C CN 1215818 C CN1215818 C CN 1215818C CN 03148156 CN03148156 CN 03148156 CN 03148156 A CN03148156 A CN 03148156A CN 1215818 C CN1215818 C CN 1215818C
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Abstract
The present invention relates to a double-layer hollow blood vessel internal support used for vascular anastomosis and a preparation method thereof. The support belongs to the technical field of biological material. The blood vessel internal support is composed of a fusiform circular pipe and an outer film, wherein the outer film covers outside the fusiform circular pipe, and both ends of the fusiform circular pipe are fusiform. The preparation method comprises: a compound is firstly dissolved and is poured into a prefabricated support mold to be slowly cooled and solidified into a mold; degradable material with film forming performance is evenly matched into water solution; the vessel support is immersed in the solution and is taken out. The blood vessel internal support made by the method of the present invention adopts a hollow structure, and blood can pass through immediately after a vascular clamp is loosened; in addition, the internal diameter of the support rapidly increases by being scoured by blood streams till the support is dissolved completely; after water is absorbed by the outer layer of the support, the outer layer of the support is rapidly expanded and softened to form the film with smoothness, high elasticity and easy deformation, which has a very low friction coefficient with the inner film of blood vessels. The film completely covers a rigid and shaggy internal layer and has no mechanical injury to the inner film of blood vessels.
Description
Technical field the present invention relates to a kind of double-layer hollow endovascular stent that is used for vascular anastomosis and preparation method thereof, is used to improve the identical quality of little blood vessel, simplifies the operation, and improves the identical speed of little blood vessel, belongs to technical field of biological materials.
The basic fundamental that the little vascular anastomosis technology of background technology is microsurgery and experimental surgery has related to all surgical fields up till now, will promote the development of whole surgery and medical science to its technical improvement.Traditional little vascular anastomosis adopts sewing, with a long history, undertaken to obtain higher patency rate by skilled doctor, be most widely used at present, by numerous doctors are accepted, but also there is inherent deficiency in it: the doctor must could grasp this technology through strict for a long time professional training, and needs regular operation or exercise could keep technical merit; Surgery duration is long, complicated operation; Requirement height to place and apparatus; Need in the sewing process blood vessel wall is carried out tractive and expansion, needlework will pass blood vessel wall and knotting, can inevitably cause damage to blood vessel wall, and cause nonvolatil foreign body residual, be anastomotic leakage blood, narrow, thrombotic main cause, thereby cause the failure that coincide.
Development along with science and technology and society has proposed requirements at the higher level to medical science.At first, the local conflicts increase can cause a large amount of appearance of war wound, rapid causes the quantity of vehicle accident and scale to continue to increase, the increase of skyscraper and the raising of population density cause the infringement great efforts amplitude of unexpected storms to rise, above reason all can cause the generation of a large amount of wounded in the short time, and double-deck multiple injury is the most common, have time enough and personnel hardly each wounded is implemented to reach the vascular anastomosis of a few hours or tens hours, severely injured personnel also is difficult to tolerance operation for a long time; Secondly, along with the source of organ and the solution of immunological rejection, organ transplantation will become the fundamental means of treatment, and novel little vascular anastomosis technology will promote the development of organ transplantation greatly; Once more, intravital biological duct of people and cavity organ are numerous, as whole digestive tract and upper respiratory tract, urogenital system mainly is made of tubing, other are as lymphatic vessel, nasolacrimal ducts etc., the present suturing skill that all adopts similar blood vessel can be used for this method the identical operation of intravital all biological pipeline in the same way.
Since sewing invention is come out people attempt always to improvement, invented several different methods, as: heat coagulable pipe coincide method, sleeve pipe or the collar coincide method and the identical method of anastomat.But owing to exist the deficiency all can extensive use, mull technique is to be expected to replace at present sewing most, mull technique must be used support, the support of development has the esters support, saccharide support, Polyethylene Glycol support at present, gelatin support etc., all there is deficiency, as: meet water or blood after-poppet intensity and significantly descend, can not play a supporting role in the overall process of coincideing; Poor toughness, frangible; The mechanical injuries tunica intima; Dissolution velocity is slow; Has cytotoxicity; Short thrombotic or the like is arranged.
Summary of the invention the objective of the invention is to propose a kind of double-layer hollow endovascular stent that is used for vascular anastomosis and preparation method thereof, prepare a kind of quick, the easy required timbering material of vascular anastomosis method, make support therewith bonding technology improve combination, improve original little vascular anastomosis method, coincideing of the little blood vessel that is used for performing the operation, and can be applied to coincideing of other tubings.
The double-layer hollow endovascular stent that is used for vascular anastomosis that the present invention proposes is made up of fusiformis pipe and theca externa, and theca externa clads outside the fusiformis pipe, and the both ends of fusiformis pipe are fusiformis, and the ratio of the interior external diameter of fusiformis pipe is 1: 2~4.
The preparation method of the double-layer hollow endovascular stent that is used for vascular anastomosis that the present invention proposes may further comprise the steps:
1, with the internal layer chemical compound heat fused of analytical pure level, and keep liquid, chemical compound can be that Polyethylene Glycol (molecular weight is 6000-20000), sucrose or dextran etc. can metabolic in vivo chemical compounds.
2, preparation fusiformis pipe: adopt the injection moulding method to pour in the prefabricated support mould chemical compound of above-mentioned maintenance liquid state, slowly cooling makes it to be frozen into the fusiformis pipe; Cylindrical die that perhaps will be identical with shelf inner diameter immerses in the liquid chemical compound, and take out the back, will adhere to one deck chemical compound at die surface, after the cooling mould is extracted out, and the chemical compound blank that solidifies is repaired, and makes it to become the fusiformis pipe;
3, the skin of making by materials such as gelatin, arabic gum or celluloses at the outer bag quilt of the fusiformis support that has made, all pharmacopeia approvals can be used in the body, can be absorbed in vivo, perhaps solvable, degradable material with film property all can be used for making outer, at first solid is made into the aqueous solution of concentration 2-30%, immerse taking-up again in the solution with making good support in the step 2 again, promptly form the film of a bed thickness 5-40 micron behind the removal moisture to be dried, become the double-deck endovascular stent of solubility on the surface.
The support that makes is sealed packing with rigid container, indicate the information such as length, internal diameter, external diameter, quality of support, with ethylene oxide or cobalt-60 sterilization, 4 ℃ of preservations.
Using method: take out the support of suitable types in the art, put into ends of vessels to be coincide, two broken ends of fractured bone are involutory, with medical bonding agent the broken ends of fractured bone is bondd, loose vascular clamp after the adhesive curing is because support is a hollow structure, promptly there is blood flow to pass through behind the pine vascular clamp, and dissolving rapidly under the washing away of blood flow.
With the novel vascular stent of method of the present invention preparation, owing to adopt hollow double-layer structure, compare with existing solid monolayer support and have the following advantages:
1, because support adopts hollow structure, promptly be carved with blood flow behind the loose vascular clamp and pass through, and internal diameter increases rapidly up to dissolving fully under the souring of blood flow, Ischemia Time obviously shortens;
2, the outer suction of support back is expanded softeningly rapidly, forms the film of smooth, good springiness, easy deformation, and is extremely low with the coefficient of friction of tunica intima, covers hard shaggy internal layer fully, do not have mechanical injuries for tunica intima;
3, the dissolution mechanism of this support and all solid supports in the past are completely different, owing to be hollow structure, the support inner surface has quick mobile blood flow to pass through, and has significantly improved dissolution velocity, make the fully dilution in blood of support component, reduced various untoward reaction;
4, intravascular stent is a hollow structure, has reduced material usage;
5, the bag quilt of outer membrane can prevent the cracked of internal layer.
The endovascular stent of the present invention's preparation, when bonding blood vessel, use, can make the speed of coincideing fast, prevent anastomotic stricture and leak blood, there is blood flow to pass through rapidly, shorten Ischemia Time, will significantly improve the patency rate of little vascular anastomosis, and wound is little, easy and simple to handle, do not need special equipment, be suitable for carrying out, can substitute sewing method fully in hospitals at different levels.
Description of drawings
Fig. 1 is the structural representation of the endovascular stent that designs of the present invention.
Among Fig. 1, the 1st, the fusiformis pipe, the 2nd, theca externa, D1 are the external diameter of fusiformis pipe, D2 is the internal diameter of fusiformis pipe.
The specific embodiment
The double-layer hollow endovascular stent that is used for vascular anastomosis that the present invention proposes, its structure is made up of fusiformis pipe 1 and theca externa 2 as shown in Figure 1, and theca externa 2 claddings are outside fusiformis pipe 1, the both ends of fusiformis pipe are fusiformis, and the ratio of the interior external diameter of fusiformis pipe is D1: D2=2~4: 1.
The raw material sources that use among the present invention: Polyethylene Glycol, gelatin, dextran, Beijing chemical reagents corporation, chemical pure level.
Embodiment one
1, it is standby with molecular weight to be that 6000 Polyethylene Glycol is heated to 70 degree back insulations.
2, will keep liquid polyethylene glycol 6000 to pour in the prefabricated mould, slowly cooling makes it coagulation forming, opens mould, takes out and makes the fusiformis pipe suitable with blood vessel diameter, and internal diameter is 0.5 millimeter, and external diameter is 1.4 millimeters, 7 millimeters of length.Make smooth with the cutter refacing.
3, the skin of making by gelatin at the fusiformis support internal layer bag quilt that has made: the aqueous gelatin solution that at first the solid gelatin is made into concentration 10%, immerse taking-up again in the gelatin solution with making good Polyethylene Glycol internal layer in the step 2 again, promptly form the gelatin film of 30 microns of bed thickness behind the removal moisture to be dried, become the soluble vascular inner support on the surface.
The above-mentioned support that makes is sealed packing with rigid container, indicate the length of support, internal diameter, external diameter, quality.Cobalt-60 sterilization, 4 ℃ of preservations.In the operation, support is taken out in unpacking, puts into blood vessel to be coincide, the involutory broken ends of fractured bone.Outside blood vessel that the broken ends of fractured bone is bonding with adhesive of medical, unclamp vascular clamp, promptly be carved with blood flow and pass through, and support dissolves rapidly.
Embodiment two
1, be that 8000 Polyethylene Glycol are made into 80% DDW solution to be heated to 70 degree back insulations standby with molecular weight.
2, will keep liquid Polyethylene Glycol 8000 to pour in the prefabricated mould, slowly cooling makes it coagulation forming, opens mould, and take out and make the fusiformis pipe suitable with blood vessel diameter, 0.2 millimeter of internal diameter, 0.8 millimeter of external diameter, 5 millimeters of length.Make smooth with the cutter refacing.
3, the skin of making by cellulose at the fusiformis support internal layer bag quilt that has made: the cellulose aqueous solution that at first solid cellulose is made into concentration 5%, immerse taking-up again in the solution with making good Polyethylene Glycol internal layer in the step 2 again, promptly form the cellulose membrane of 20 microns of bed thickness behind the removal moisture to be dried, become the soluble vascular inner support on the surface.
The support that makes is sealed packing with rigid container, indicate the length of support, internal diameter, external diameter, quality.The ethylene oxide sterilization, 4 ℃ of preservations.In the operation, support is taken out in unpacking, puts into blood vessel to be coincide, the involutory broken ends of fractured bone.Outside blood vessel that the broken ends of fractured bone is bonding with adhesive of medical, unclamp vascular clamp, promptly be carved with blood flow and pass through, and support dissolves rapidly.
Embodiment three
1, be that 10000 Polyethylene Glycol is made 60% DDW solution with molecular weight, it is standby to be heated to 80 degree back insulations.
2, the cylindrical die with 1 millimeter of diameter immerses taking-up again in the liquid cetomacrogol 1000 0, after the cooling mould is extracted out, and the Polyethylene Glycol blank that solidifies is repaired, and makes it to become the fusiformis that needs, 1 millimeter of internal diameter, 2 millimeters of external diameters, 7 millimeters of length.Make smooth with the cutter refacing.
3, the skin of making by arabic gum at the fusiformis support internal layer bag quilt that has made: the arabic gum aqueous solution that at first the solid arabic gum is made into concentration 20%, immerse taking-up again in the gumwater with making good Polyethylene Glycol internal layer in the step 2 again, promptly form the Arabic glued membrane of 30 microns of bed thickness behind the removal moisture to be dried, become the soluble vascular inner support on the surface.
The support that makes is sealed packing with rigid container, indicate the length of support, internal diameter, external diameter, quality.Cobalt-60 sterilization, 4 ℃ of preservations.In the operation, get the support of suitable types, put into blood vessel to be coincide, the involutory broken ends of fractured bone.Outside blood vessel that the broken ends of fractured bone is bonding with adhesive of medical, unclamp vascular clamp, promptly be carved with blood flow and pass through, and support dissolves rapidly.
Embodiment four
1, is to become liquid state after 12000 Polyethylene Glycol is heated to 80 degree with molecular weight, is incubated standby.
2, will keep liquid Polyethylene Glycol 12000 to pour in the prefabricated mould, slowly cooling makes it coagulation forming, opens mould, takes out and makes the fusiformis pipe suitable with blood vessel diameter, and internal diameter is 0.5 millimeter, 1.5 millimeters of external diameters, and length is 6 millimeters.Make smooth with the cutter refacing.
3, the skin of making by gelatin at the fusiformis support internal layer bag quilt that has made: the aqueous gelatin solution that at first the solid gelatin is made into concentration 5%, immerse taking-up again in the gelatin solution with making good Polyethylene Glycol internal layer in the step 2 again, promptly form the gelatin film of 10 microns of bed thickness behind the removal moisture to be dried, become the soluble vascular inner support on the surface.
The support that makes is sealed packing with rigid container, indicate the length of support, internal diameter, external diameter, quality.Cobalt-60 sterilization, 4 ℃ of preservations.In the operation, support is taken out in unpacking, puts into blood vessel to be coincide, the involutory broken ends of fractured bone.Outside blood vessel that the broken ends of fractured bone is bonding with adhesive of medical, unclamp vascular clamp, promptly be carved with blood flow and pass through, and support dissolves rapidly.
Embodiment five
1, is to become liquid state after 20000 Polyethylene Glycol is heated to 90 degree with molecular weight, is incubated standby.
2, will keep liquid Macrogol 2000 0 to pour in the prefabricated mould, slowly cooling makes it coagulation forming, opens mould, takes out and makes the fusiformis pipe suitable with blood vessel diameter, and internal diameter is 0.3 millimeter, and external diameter is 1 millimeter, 5 millimeters of length.Make smooth with the cutter refacing.
3, the skin of making by gelatin at the fusiformis support internal layer bag quilt that has made: the aqueous gelatin solution that at first the solid gelatin is made into concentration 3%, immerse taking-up again in the gelatin solution with making good Polyethylene Glycol internal layer in the step 2 again, promptly form the gelatin film of 5 microns of bed thickness behind the removal moisture to be dried, become the soluble vascular inner support on the surface.
The support that makes is sealed packing with rigid container, indicate the length of support, internal diameter, external diameter, quality.Cobalt-60 sterilization, 4 ℃ of preservations.In the operation, support is taken out in unpacking, puts into blood vessel to be coincide, the involutory broken ends of fractured bone.Outside blood vessel that the broken ends of fractured bone is bonding with adhesive of medical, unclamp vascular clamp, promptly be carved with blood flow and pass through, and support dissolves rapidly.
Embodiment six
1, sucrose being heated to liquid back is incubated standby.
2, will keep liquid sucrose to go in the prefabricated mould, slowly cooling makes it coagulation forming, opens mould, takes out, and makes the fusiformis pipe through pruning, and 1 millimeter of internal diameter, external diameter are 2 millimeters, 6 millimeters of length.Make smooth with the cutter refacing.
3, the skin of making by gelatin at the fusiformis support internal layer bag quilt that has made: the aqueous gelatin solution that at first the solid gelatin is made into concentration 10%, immerse taking-up again in the gelatin solution with making good sucrose internal layer in the step 2 again, promptly form the gelatin film of 30 microns of bed thickness behind the removal moisture to be dried, become solubility double-layer scaffold material on the surface.
The support that makes is sealed packing with rigid container, indicate the length of support, internal diameter, external diameter, quality.-60 sterilizations of ethylene oxide or cobalt, 4 ℃ of preservations.In the operation, support is taken out in unpacking, puts into blood vessel to be coincide, the involutory broken ends of fractured bone.Outside blood vessel that the broken ends of fractured bone is bonding with adhesive of medical, unclamp vascular clamp, promptly be carved with blood flow and pass through, and support dissolves rapidly.
Embodiment seven
1, solid dextran heating liquid back insulation is standby.
2, the cylindrical die with 0.4 millimeter of diameter immerses back taking-up in the liquid dextran, after the cooling mould is extracted out, and the chemical compound blank that solidifies is repaired, and making it becomes the fusiformis that needs, and internal diameter is 0.4 millimeter, and external diameter is 1.3 millimeters, 5 millimeters of length.
3, the skin of making by gelatin at the fusiformis support internal layer bag quilt that has made: the aqueous gelatin solution that at first the solid gelatin is made into concentration 10%, immerse taking-up again in the gelatin solution with making good sucrose internal layer in the step 2 again, promptly form the gelatin film of 20 microns of bed thickness behind the removal moisture to be dried, be solubility double-layer scaffold material behind the removal moisture to be dried on the surface.
The support that makes is sealed packing with rigid container, indicate the length of support, internal diameter, external diameter, quality.-60 sterilizations of ethylene oxide or cobalt, 4 ℃ of preservations.In the operation, support is taken out in unpacking, puts into blood vessel to be coincide, the involutory broken ends of fractured bone.Outside blood vessel that the broken ends of fractured bone is bonding with adhesive of medical, unclamp vascular clamp, promptly be carved with blood flow and pass through, and support dissolves rapidly.
Claims (2)
1, a kind of double-layer hollow endovascular stent that is used for vascular anastomosis, it is characterized in that this endovascular stent is made up of fusiformis pipe and theca externa, the theca externa cladding is outside the fusiformis pipe, and the both ends of fusiformis pipe are fusiformis, and the ratio of the interior external diameter of fusiformis pipe is 1: 2~4.
2, a kind of preparation method that is used for the double-layer hollow endovascular stent of vascular anastomosis is characterized in that this method may further comprise the steps:
(1) can metabolic in vivo chemical compound heat fused, and keep liquid standby, describedly can metabolic in vivo chemical compound be: molecular weight be any in 6000-20000 Polyethylene Glycol, sucrose or the dextran;
(2) preparation fusiformis pipe: adopt the injection moulding method to pour in the prefabricated support mould chemical compound of above-mentioned maintenance liquid state, slowly cooling makes it to be frozen into the fusiformis pipe; Cylindrical die that perhaps will be identical with shelf inner diameter immerses in the liquid chemical compound, and take out the back, will adhere to one deck chemical compound at die surface, after the cooling mould is extracted out, and the chemical compound blank that solidifies is repaired, and makes it to become the fusiformis pipe;
(3) the film property material is made into the aqueous solution of concentration 2-30%, fusiformis pipe with preparation in the step (2) immerses taking-up again in the solution again, behind the removal moisture to be dried, promptly forming thickness at the fusiformis tube-surface is the film of 5-40 micron, become endovascular stent, described film property material is any in gelatin, arabic gum or the cellulose.
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CN 03148156 CN1215818C (en) | 2003-07-04 | 2003-07-04 | Double layer hollow blood vessel internal support used for vascular anastomosis and its preparation method |
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CN1215818C true CN1215818C (en) | 2005-08-24 |
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Families Citing this family (8)
Publication number | Priority date | Publication date | Assignee | Title |
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CN100522078C (en) * | 2006-09-18 | 2009-08-05 | 广州医学院第二附属医院 | Major vessels anastomosis device |
CN101066478B (en) * | 2007-05-24 | 2011-05-04 | 中国医学科学院生物医学工程研究所 | Biodegradable slow released medicated rack for myocardial blood transport reconstruction and its preparation process |
CN101732112A (en) * | 2008-11-27 | 2010-06-16 | 梁向党 | Development of instant bracket for bonding biliary tract or ureter |
CN101732113A (en) * | 2008-11-27 | 2010-06-16 | 梁向党 | Preparation method of special instant dissolved stent for intestinal adhesion |
CN101732111A (en) * | 2008-11-27 | 2010-06-16 | 梁向党 | Method for preparing T-shaped instant stent for end-to-side adhesion of biological duct |
CN101934091B (en) * | 2010-09-07 | 2013-10-30 | 德州海利安生物科技股份有限公司 | Polysaccharide artificial blood vessel and preparation method and application thereof |
CN102346128B (en) * | 2011-07-08 | 2013-01-02 | 西安交通大学 | Method for testing surface friction performance of living vascular endothelial cell |
CN104257441B (en) * | 2014-10-17 | 2016-03-23 | 王洛 | To meet an urgent need the cover connected components rebuild for blood vessel, intestinal tube |
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