CN101961504B - Gel coating accessory capable of preventing spinal surgery cerebrospinal fluid leakage - Google Patents
Gel coating accessory capable of preventing spinal surgery cerebrospinal fluid leakage Download PDFInfo
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- CN101961504B CN101961504B CN201010253842.XA CN201010253842A CN101961504B CN 101961504 B CN101961504 B CN 101961504B CN 201010253842 A CN201010253842 A CN 201010253842A CN 101961504 B CN101961504 B CN 101961504B
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Abstract
The invention relates to a gel coating accessory capable of preventing spinal surgery cerebrospinal fluid leakage, comprising a first fluid component in a first buffer solution which contains lysine, dimeric lysine or polylysine and has the pH value of 3-12 in a first container, a second fluid component of a second buffer solution with the pH value of 3-12 in a second container, a combined solid component which is composed of poly (trimethylene carbonate), polylactic acid, polyethylene glycol, polyethylene glycol polytomy isomer, polyurethane, gelatine, polyphosphate, polyglycolic acid and copolymer thereof and blend thereof in a third container as well as a coating tool. Optionally, infusion medicament which is used after spinal surgery can be contained in the first fluid component, the second fluid component and the solid component. When the first fluid component, the second fluid component and the solid component are mixed, gel is formed, and the gel can be directly coated onto the part used for preventing spinal surgery cerebrospinal fluid leakage.
Description
Technical field
The present invention relates to medical instruments field, especially relate to the operation external member for the antiseepage of stopping blooding.
Technical background
Surgical operation and wound all can be formed with blood wound surface, have a large amount of loss of blood therebetween, need to adopt in time hemostasis means.The absorbable hemostatic material that use has biocompatibility is a kind of common hemostasis means in there being the hemostasis of blood wound surface, when hemostasis is saved oneself by surgery surgical hemostasis, wound, first aid, family, all there is urgent needs, the importance of a kind of hemostatic material safe, effective, easy to use and with low cost to human health is provided as can be seen here.Cerebrospinal leak is one of spinal surgery infectious-related complication, and lasting cerebrospinal leak can hinder wound healing, if treatment not in time or deal with improperly, can cause injury mouthful do not heal, wound infection, meningitis, spinal canal infection even.Symptom and sign has other symptoms such as headache, dizzy, meningismus, Low cranial pressure, sensory disturbance, to patient, causes great misery and inconvenience.
Existing conventional absorbable hemostatic material comprises following several:
1, sthptic sponge (SPONGE) class: gelfoam, collagen protein sponge, chitosan sthptic sponge, carboxymethyl cellulose sthptic sponge, containing thrombin or fibrinous sthptic sponge;
2, hemostatic gauze/haemostatic membrane (GAUZE, FILM) class: oxidized cellulose, oxidized regenerated cellulose hemostatic gauze, containing the oxidized cellulose hemostatic gauze of carboxymethyl cellulose;
3, colloid styptic class: Fibrin Glue, synthetic glue;
4, polysaccharide styptic powder class: micropore polysaccharide styptic powder, chitosan styptic powder, algae styptic powder
Below conventional biocompatible hemostatic material is made a concrete analysis of:
1, absorbability gelfoam and collagen protein sponge
Gelfoam derives from the extract of animal tissue, and its main component is animal collagen.Its hydrophilic and loose structure be the moisture in absorbing blood and concentrate blood rapidly, thereby reaches the object of hemostasis.But gelatin is the collagen extract that derives from animal, containing foreign protein, easily cause allergic reaction, the symptom such as can cause that patient generates heat clinically; Meanwhile, human body is slower to the absorption of gelfoam, is generally more than 4 weeks, therefore can increase the infection rate of wound, affects wound healing.Collagen protein sponge also derives from the collagen extract of animal tissue.Except can be by the moisture in absorbing blood concentrate blood, can also be the same with gelfoam by activating intrinsic coagulation mechanism, the raw material sources of collagen protein sponge are in animal, for foreign protein: and human body absorbs slow to its, show as clinically patient allergy reaction, wound healing is slow and the susceptible complication of wound, therefore clinical use is greatly limited.
2, oxidized cellulose (Oxidized Cellulose), oxidized regenerated cellulose (Oxidized regenerated cellulose) hemostatic gauze
Oxidized cellulose is a kind of of cellulose derivative.Its hemostatic mechanism is the characteristic that absorbs water by material and concentrate blood starts clotting mechanism; Meanwhile, carboxyl is combined with Hemoglobin F e, makes blood produce acid haematin, forms brown blob of viscose, sealing blood capillary end and stopping blooding.Oxidized regenerated cellulose is identical with the hemostatic mechanism of oxidized cellulose.
Oxidized cellulose is synthetic.Normal tissue is the enzyme of metabolism oxidized cellulose and relatively slow to this series products degradation speed for want of, be at least 3～6 weeks according to the general time absorbing in vivo of the position of consumption and use, clinical cause local infection and affect local organization heal.Publication number CN1533751A discloses a kind of hemostatic wound dressing, commodity are called SURGICEL, comprise fabric and be coated on the surface that fabric contacts with wound and be scattered at least partly the porous polymer substrate in fabric, this substrate comprises biocompatible water solublity or water-swellable polymer, and the fiber of fabric is oxidized regenerated cellulose, water solublity or water-swellable polymer are polysaccharide.But the main body that this bleeding-stopping dressing is selected is the cellulose of oxidation, and absorption of human body is slow, and it organizes adhesive force poor, so clinical practice is restricted.
3, Fibrin Glue (Fibrin glue)
Fibrin Glue is comprised of Fibrinogen, thrombin, aprotinin and calcium chloride.Anastalsis is mainly the blood coagulation that thrombin activation Fibrinogen promotes body.In recent years clinical practice is fibrin sealant comparatively widely, is the mixing arrangement of Fibrinogen and thrombin.Thrombin in Fibrin Glue and fibrin derive from human body or animal, easily cause patient allergy reaction, and cause infecting humanized and zoonosis, as hepatitis, acquired immune deficiency syndrome (AIDS), bovine spongiform encephalopathy etc.Fibrin Glue be applied in moistening adhesiveness while organizing wound surface a little less than, can not effectively control active hemorrhage.And albumin glue is difficult for storage and transportation, uses inconvenience.
4, natural biological polysaccharide product
In recent years, the production development of natural biological polysaccharide is rapid, receives publicity.For the natural biological polysaccharide product stopping blooding, be plant polysaccharide and chitosan at present.Their good biocompatibility, nontoxic, non-stimulated, be difficult for causing the anaphylaxis of body, can not cause and infect or infection humanized and zoonosis simultaneously.
(1) chitosan/chitin kind product
The product of chitosan/chitin is representational is high swollen molten chitosan sponge, is to take natural marine organism extract chitosan to be made as raw material.Chitosan has good water absorption, can cause and accelerate to start the clotting mechanism of self and therefore coagulant can become the hemorrhage of external.But owing to lacking the enzyme that it is effectively degraded rapidly in human body, the method that there is no is used in surgical operation.At present, there is not yet the report that its hemostatic material as III class is stopped blooding for Clinical Surgery's art both at home and abroad.
(2) micropore polysaccharide-(Microporous Polysaccharide Hemospheres, MPH)
2002, a kind of absorbable hemostasia material (US Patent No. 6060461) that is called AristaTM of the Medafor company research and development of the U.S., its effective ingredient is many micropore polysaccharides, comprises glucosan.This micropore polysaccharide is reacted and makes with chloropropylene oxide by polysaccharide, and chloropropylene oxide and starch molecule effect generation ethyl glycerol with hydroxyl, can make glucose molecule be cross-linked into tridimensional network.
Arista
tMhemostatic material exists some problems.First, from application surface, this hemostatic material is mainly still confined to the hemostasis of skin or soft tissue wound surface, and to the histoorgan in body cavity deep, the particularly hemostasis of Microendoscopic (as Minimally Invasive Surgerys such as gastroscope, intestinal mirror and peritoneoscopes time) of stopping blooding still lacks effective means; The second, preparation method, chloropropylene oxide is colourless oil liquid, and therefore toxic and narcoticness produces this product unfavorable to environmental protection, and production cost is also higher; The 3rd, from haemostatic effect, because its water absorption is strong not, water absorbent rate is low, and the speed of water suction is slower, and haemostatic effect is undesirable, not good enough to active hemorrhage haemostatic effect especially; The 4th, its viscosity is low, and the gel viscosity forming after water suction is poor, therefore with blood effect after the sludged blood and the poor adhesion of tissue that form, can not produce effective viscosity shutoff to damaged tissue, blood vessel, thereby the impact effect of stopping blooding; The 5th, when active hemorrhage, styptic powder is difficult to be attached to hemorrhage place, easily by blood flow, is washed away, if press with adjuvant on styptic powder, adjuvant is easy to, by sludged blood adhesion, cause again hemorrhage while opening adjuvant.Therefore, bad to active hemorrhage haemostatic effect.
The object of the invention is to overcome the deficiencies in the prior art, the gel application kit of cerebrospinal fluid seepage after a kind of new prevented spinal surgery is provided, the gel that described external member is used has good biological degradability, biocompatibility, security reliability.
Summary of the invention
In order to complete foregoing invention object, the invention provides a kind of gel application kit that prevents cerebrospinal fluid seepage after spinal surgery, described external member comprises:
A) the first fluid component in the first container of sealing, described first fluid component comprises that it is the solution forming in the first buffer solution between 3 to 12 that the lysine compounds of the group of selecting free lysine, two polylysines, poly-D-lysine and combination composition thereof is dissolved in pH value;
B) the second fluid component in the second container of sealing, described second fluid component is that pH value is the second buffer solution between 3 to 12;
C) solid constituent in the 3rd container of sealing, described solid constituent comprises medical macromolecular materials, described medical macromolecular materials select free PTMC, polylactic acid, Polyethylene Glycol, the isomer of Polyethylene Glycol multi-branched, glutin, polyurethane, gelatin, poly phosphate, the group that polyglycolic acid and copolymer thereof and blend form, and described medical macromolecular materials have with 1% concentration be dissolved in the chloroform solvent of 25 ℃, with Ubbelohde viscometer, record 0.01 to 5dl/g, be preferably 0.05 intrinsic viscosity of arriving in the scope of 0.2dl/g, and
D) coating tool;
And,
Described first fluid component, described second fluid component and described solid constituent form the formula of described gel application kit, gross weight in described formula, the percentage by weight of described lysine compounds is 0.1%～30%, is preferably 0.1%～10%; The percentage by weight of described medical macromolecular materials is 1%-70%; Volume ratio between described first fluid component and described second fluid component is from 30: 70 to 70: 30, is preferably 40: 60 to 60: 40, more preferably 45: 55 to 55: 45; And, when described first fluid component, described second fluid component and described solid constituent are mixed, jointly form gel.
In some embodiments, described the first buffer solution and the second buffer solution are selected from phosphate buffer solution and borate buffer solution independently of one another.
In some embodiments, described the first buffer solution be pH6 to 12 borate buffers, described the second buffer solution is the phosphate buffer solution of pH 3 to 11.
In some embodiments, the weight average molecular weight of described medical macromolecular materials is 1000 to 300,000 dalton, preferably in 2000 to 50,000 scope.
In some embodiments, described first fluid component, described second fluid component or described solid constituent one or more of also comprise choosing freely stop blooding class medicine, alleviate cellular edema class medicine, antibiotics, antiviral class medicine and combine the medicine of the group of composition, and, in the gross weight of described formula, the percetage by weight of described medicine is 0.01%～20%.
In some embodiments, described hemostasis class medicine is selected from tranexamic acid and hemocoagulase; The described cellular edema class medicine that alleviates is aescine; Described antibiotics is selected from penicillin, cephalosporin, vancomycin, tobramycin, amikacin and gentamycin and dexamethasone; Described antiviral class medicine is selected from virazole, acyclovir and ganciclovir.
In some embodiments, described solid constituent is the powder of homogeneous.
In some embodiments, one or more of in described first fluid component, described second fluid component and described solid constituent also comprise medical stain, and in the gross weight of described formula, the percetage by weight of described medical stain is 1: 100～10: 100.
In some embodiments, described coating tool is used for forming after macromolecular material fluid the described solid constituent in described the 3rd container being dissolved into second fluid component in described second container, the described macromolecular material fluid in the first fluid component in described the first container and described second container is mixed to the position that is coated to cerebrospinal fluid seepage after described spinal surgery.
The gel application kit that prevents cerebrospinal fluid seepage after spinal surgery provided by the present invention, when the clinical spinal operation of doctor, spinal dura mater is coated on wound surface after sewing up, good biological degradability, biocompatibility, the security reliability of utilizing this colloidal material itself to possess, prevent postoperative because cerebrospinal fluid oozes out the adverse events such as infection of initiation, and, when described gel carries medicine, can delay Slow release, reduce or avoid seepage to occur and promote wound healing.When this product is used, be transparent colloid, in 1 year, can be hydrolyzed, metabolism goes out external.During use, by blender, its terminal double bond is formed two or more fluids mixing crosslinked, seal the tissue site of oozing of blood sepage, thereby reach the object of hemostasis antiseepage.
Accompanying drawing explanation
Fig. 1 is the schematic diagram that prevents the gel application kit of cerebrospinal fluid seepage after spinal surgery of the present invention.
Fig. 2 is the gel application kit that prevents cerebrospinal fluid seepage after spinal surgery of the present invention schematic diagram in use.
The specific embodiment
As shown in Figure 1, provided by the present invention prevent spinal surgery after the gel application kit 100 of cerebrospinal fluid seepage comprise the first fluid component 11 that is carried in the first container 10, be carried on second fluid component 21 in second container 20, be carried on solid constituent 31 and coating tool 40 in the 3rd container 30.During use, described solid constituent 31 in described the 3rd container 30 is dissolved into second fluid component in described second container 20 21 and forms after macromolecular material fluids, by the described macromolecular material fluid in the first fluid component 11 in described the first container 10 and described second container 20 by being mixed to form gel.By means of coating tool 40, the gel of formation can be applied directly to the position of cerebrospinal fluid seepage after spinal surgery.
In first fluid component 11, lysine compounds is selected from the group that lysine, two polylysines, poly-D-lysine and combination form, wherein, and preferably two polylysines or three polylysines.Lysine compounds accounts for 0.1%～30% of described formula gross weight, is preferably 0.1%～10%.
In first fluid component 11 is that the first buffer solution between 3 to 12 is generally phosphate buffer solution or borate buffer solution at pH value, also can use other conventional medical buffer solution.Preferably, the first buffer solution is the borate buffer of pH 6 to 12.
Described first fluid component 11 seals preservation in the first container 10.
Described second fluid component 21, for pH value is the second buffer solution between 3 to 12, is generally phosphate buffer solution or borate buffer solution, also can use other conventional medical buffer solution.Described the second buffer solution can with first fluid component 11 in the first buffer solution identical or different.Preferably, the second buffer solution is the phosphate buffer of pH 3 to 11.
Described second fluid component 21, or alternatively, described in comprise for the second fluid component 21 of the infusion medicament medicine after spinal surgery and preserve in second container 20 sealings.
The volume of described first fluid component 11 and described second fluid component 21 can be identical or different, and volume ratio between the two, from 30: 70 to 70: 30, is preferably 40: 60 to 60: 40, more preferably 45: 55 to 55: 45.For easy to use, both volumes are substantially the same.
Described solid constituent 31 seals preservation in the 3rd container 30.Described solid constituent 31 comprises medical macromolecular materials, described medical macromolecular materials comprise the homogenous material, the copolymer between two or more of PTMC and PLA copolymer, Polyethylene Glycol and multi-branched isomer thereof, glutin, polyurethane, gelatin, poly phosphate, polyglycolic acid or any one in blend, and its copolymerization or blend weight ratio are all 1%: 99%-99%: in 1% scope.Its intrinsic viscosity of its blend or copolymer (dark type viscometer, chloroform solvent 1% concentration, 25 ℃) scope is the wherein best 0.05-0.2dl/g of being of 0.01-5dl/g.; Weight average molecular weight range is 1000-300000 dalton, and wherein the best is 2000-50000 dalton.
In the gross weight of described formula, the percentage by weight of described medical macromolecular materials is 1%-70%.
Described gel application kit can also comprise for the infusion medicament medicine after spinal surgery, and described medicine is selected from 1, hemostasis class: tranexamic acid, hemocoagulase; 2, alleviate cellular edema class: aescine; 3, antibiotics: penicillin, cephalosporin, vancomycin, tobramycin, amikacin, gentamycin and dexamethasone; 4, antiviral class: any or its combination in virazole, acyclovir and ganciclovir etc.In view of the consideration to selected medicine stability, described medicine can be included in described first fluid component 11, described second fluid component 21 or described solid constituent 31.Certainly, described medicine can also can be present in the 4th container (not shown) of sealing individually.Preferably, described is by by its any one or its combination is dissolved in the phosphate buffer solution of pH value between 3 to 12 or borate buffer solution forms for the infusion medicament medicine after spinal surgery.In the gross weight of described formula, the percetage by weight of described medicine is 0.01%～20%.According to the stability of selected medicine, those skilled in the art can determine that any in above three kinds of components or which described medicine be present in by conventional method.Usually, described drug component is present in second fluid component.
Described gel application kit also comprises medical stain, and described medical stain can be one or more, is used to indicate each component in gel application kit, be convenient to coating before preparation and application subsequently.Described medical stain can be included in one or more of in described first fluid component 11, described second fluid component 21 and described solid constituent 31.Described medical stain can be commonly use for medical stain, one of described first fluid component 11, described second fluid component 21 or the described solid constituent 31 before making preparation or after preparation or wherein two kinds or all present as colors such as red, orange, yellow, green, cyan, blue, purple.In the gross weight of described formula, the percetage by weight of described medical stain is 0.01%～5%.
Described coating tool 40 be used for by again draw back second container 20 dissolving the macromolecular material fluid of solid constituent 31 mix with the first fluid component 11 in the first container, and be coated to the position of cerebrospinal fluid seepage after described spinal surgery.
Preferably, described coating tool 40 comprises two or more syringes, multi-syringe pushing ram binding rack, threeway or leads to hybrid junctioin and atomizer more.As shown in Figure 2, two syringes 410 and 420 and can distinguish and be directly used as described the first container 10 and second container 20, for carrying respectively described first fluid component 11 and described second fluid component 21.With syringe 420, second fluid component 21 being injected to the 3rd container 30, dissolve after described solid constituent 31, the macromolecular material fluid 22 that has dissolved solid constituent 31 is drawn back in syringe 420 again.Atomizer 450 and multi-syringe pushing ram binding rack 460 by means of threeway hybrid junctioin 440 and front end thereof, first fluid component 11 and macromolecular material fluid 22 can be formed to gel 70 by means of promoting multi-syringe pushing ram binding rack 460 after threeway hybrid junctioin 440 and atomizer 450 fully mix, described gel 70 can be applied directly to the position (not shown) that is coated to cerebrospinal fluid seepage after described spinal surgery.
Syringe 410,420 is shaped as cylindrical cuboid or polygon, and the material of syringe 410,420, multi-syringe pushing ram binding rack 460, threeway or how logical hybrid junctioin 440 and atomizer 450 is medical glass or medical plastic.
In gel application kit of the present invention, included coating tool is not limited to above-mentioned form, other, such as utilizing manual mixing to form the instrument applying again after gel, also can use, to complete the present invention.
Of the present inventionly prevent that the gel application kit of cerebrospinal fluid seepage after spinal surgery can be according to the conventional method preparation of this area, for instance, described external member can be prepared in accordance with the following steps.
Macromolecule medical material, through grinding after homogenizing, is added to medical stain and/or medicine alternatively, make the solid constituent 31 of homogeneous particle diameter powder, such material is used for many years at clinical safety, is a kind of safe material that can be implanted at human body.Automatically pack artificial after the material accurate weighing mixing or equipment in bottle (the 3rd container 30) vacuum seal.
Prepare respectively first fluid component 11 and second fluid component 21, afterwards, respectively artificial or automatic canning is in the first container 10 and second container 20, preferably, described the first container 10 and second container 20 are formed the form of syringe, and syringe 410,420, respectively sealing.
By the first container 10, second container 20 and the 3rd container 30, together with after coating tool 40 packing through irradiation or gaseous sterilization.
Front opening packing to be used, second fluid component in second container 20 21 is injected to the solid constituent 31 of the 3rd container 30, to be mixedly draw back second container 20 after evenly, when the first container 10 and second container 20 are the container of syringe form, two syringes 410,420 can be tied on shelf 460 simultaneously, at syringe front end, load onto threeway hybrid junctioin 440, and at the port of export of described threeway hybrid junctioin 440, the rear injection rod that simultaneously advances two syringes of nozzle 450 is installed.When two or more solution process blenders and nozzle, mix and form rapidly cross-linking reaction, just after contacting tissue, forming gelinite.
The pH value of mixed gel solution 70 is between 6 to 9, and gelation rate is between 1 second to 30 seconds.The degradation time of final gelatinous mass is 1 week to 1 year.The medicament slow release time of final gelatinous mass is 3 days to 180 days.
By specific embodiment, explain in detail the present invention below.It should be noted that, disclosed specific embodiment is only used for illustrating the present invention, rather than is used for limiting claimed scope of the present invention.The scope of protection of present invention is specifically limited by claim.
Each element of coating tool is manufactured by the inventor, and material is medical plastic.
Embodiment 1
Gel application kit:
1) first fluid component: (pH 6 for the borate buffer of poly-D-lysine (0.1g); 5ml);
2) second fluid component: (pH 11 for phosphate buffer; 5ml), be wherein dissolved with dexamethasone (0.1g);
3) solid constituent: PTMC and PLA copolymer (2g; Weight average molecular weight 12KD);
4) coated tool: (as shown in Figure 2).
Preparation: the 5ml borate buffer that is first 6 by 0.1g poly-D-lysine powder dissolution in pH value, then in the 5ml phosphate buffer that is 11 in pH value by 0.1g dexamethasone powder dissolution, and difference fill is in two syringes 410 and 420; The PTMC and the PLA copolymer powder that weigh 2g weight average molecular weight 12KD are loaded in the 3rd container 30; Configuration coated tool; Pack; Irradiation sterilization;
Application: before use the solid constituent 31 in the 3rd container 30 is dissolved in to the second fluid component 21 in syringe 420, simultaneously two syringes 410 and 420 front ends install additional and inject two kinds of liquid after threeway and nozzle simultaneously it is mixed rapidly at nozzle place, after being sprayed at wound, form gel, final wound closure.
Embodiment 2:
Gel application kit:
1) first fluid component: (pH 10 for the borate buffer of poly-D-lysine (0.04g); 2ml);
2) second fluid component: (pH 4 for phosphate buffer; 5ml);
3) solid constituent: Polyethylene Glycol multi-branched isomer (0.7g; Weight average molecular weight 30KD);
4) coated tool: (as shown in Figure 2).
Preparation: the 2ml borate buffer that is first 10 by 0.04g poly-D-lysine powder dissolution in pH value, then the 5ml phosphate buffer that is 4 by pH value, fill is in two syringes 410 and 420 respectively; The Polyethylene Glycol multi-branched isomer powder that weighs 0.7g weight average molecular weight 30KD is loaded in the 3rd container 30; Configuration coated tool; Pack; Irradiation sterilization;
Application: before use the solid constituent 31 in the 3rd container 30 is dissolved in to the second fluid component 21 in syringe 420, simultaneously two syringes 410 and 420 front ends install additional and inject two kinds of liquid after threeway and nozzle simultaneously it is mixed rapidly at nozzle place, after being sprayed at wound, form gel, final wound closure.
Embodiment 3:
Gel application kit:
1) first fluid component: (pH 12 for the borate buffer of two polylysines (0.2g); 5ml);
2) second fluid component: (pH 3 for phosphate buffer; 5ml);
3) solid constituent: gelatin (0.1g) and glutin (1g; Weight average molecular weight 30KD);
4) coated tool: (as shown in Figure 2).
Preparation: first 0.2g dimerization lysine powder is dissolved in to pH value and is 12 5ml borate buffer, then the 5ml phosphate buffer that is 3 by pH value, fill is in two syringes 410 and 420 respectively; Weighing 0.1g gelatin powder and 1g weight average molecular weight 30KD glutin powder is loaded in the 3rd container 30; Configuration coated tool; Pack; Irradiation sterilization;
Application: before use the solid constituent 31 in the 3rd container 30 is dissolved in to the second fluid component 21 in syringe 420, two syringes 410 and 420 front ends install additional injects two kinds of liquid after threeway and nozzle simultaneously it is mixed rapidly at nozzle place, after being sprayed at wound, form gel, final wound closure.
Embodiment 4:
Gel application kit:
1) first fluid component: (pH 8 for the borate buffer of poly-D-lysine (0.5g); 5ml);
2) second fluid component: (pH 5 for phosphate buffer; 5ml), be wherein dissolved with cephamycin (0.01g);
3) solid constituent: polyglycolic acid (5g; Weight average molecular weight 8KD);
4) coated tool: (as shown in Figure 2).
Preparation: the 5ml borate buffer that is first 8 by 0.5g poly-D-lysine powder dissolution in pH value, then in the 5ml phosphate buffer that is 5 in pH value by 0.01g cephamycin powder dissolution, and difference fill is in two syringes 410 and 420; The polyglycolic acid powder that weighs 5g weight average molecular weight 8KD is loaded in the 3rd container 30; Configuration coated tool; Pack; Irradiation sterilization;
Application: before use the solid constituent 31 in the 3rd container 30 is dissolved in to the second fluid component 21 in syringe 420, two syringes 410 and 420 front ends install additional injects two kinds of liquid after threeway and nozzle simultaneously it is mixed rapidly at nozzle place, after being sprayed at wound, form gel, final wound closure.
Embodiment 5:
Gel application kit:
1) first fluid component: (pH 7 for the borate buffer of poly-D-lysine (0.01g); 3ml);
2) second fluid component: (pH 7 for phosphate buffer; 3ml);
3) solid constituent: poly phosphate (0.01g; Weight average molecular weight 80KD);
4) coated tool (as shown in Figure 2).
Preparation: the 3ml borate buffer that is first 7 by 0.01g poly-D-lysine powder dissolution in pH value, then the 3ml phosphate buffer that is 7 by pH value, fill is in two syringes 410 and 420 respectively; The poly phosphate powder that weighs 0.01g weight average molecular weight 80KD is loaded in the 3rd container 30; Configuration coated tool; Pack; Irradiation sterilization;
Application: before use the solid constituent 31 in the 3rd container 30 is dissolved in to the second fluid component 21 in syringe 420, two syringes 410 and 420 front ends install additional injects two kinds of liquid after threeway and nozzle simultaneously it is mixed rapidly at nozzle place, after being sprayed at wound, form gel, final wound closure.
Embodiment 6:
Gel application kit:
1) first fluid component: (pH 11 for the borate buffer of poly-D-lysine (0.001g); 1ml);
2) second fluid component: (pH 4.5 for phosphate buffer; 1ml), be wherein dissolved with dexamethasone (0.01g);
3) solid constituent: Polyethylene Glycol multiple-limb isomer (0.2g; Weight average molecular weight 5KD);
4) coated tool: (as shown in Figure 2).
Preparation: the 1ml borate buffer that is first 11 by 0.001g poly-D-lysine powder dissolution in pH value, then in the 1ml phosphate buffer that is 4.5 in pH value by 0.01g dexamethasone powder dissolution, and difference fill is in two syringes 410 and 420; The Polyethylene Glycol multiple-limb isomer powder that weighs 0.2g weight average molecular weight 5KD is loaded in the 3rd container 30; Configuration coated tool; Pack; Irradiation sterilization;
Application; Before use the solid constituent 31 in the 3rd container 30 is dissolved in to the second fluid component 21 in syringe 420, two syringes 410 and 420 front ends install additional injects two kinds of liquid after threeway and nozzle simultaneously it is mixed rapidly at nozzle place, after being sprayed at wound, form gel, final wound closure.
Embodiment 7:
Gel application kit:
1) first fluid component: (pH 12 for the borate buffer of poly-D-lysine (0.15g); 1ml);
2) second fluid component: (pH 3 for phosphate buffer; 1ml), be wherein dissolved with hemocoagulase (0.5g);
3) solid constituent: polyurethane (3g; Weight average molecular weight 5KD);
4) coated tool: (as shown in Figure 2).
Preparation: the 1ml borate buffer that is first 12 by 0.15g poly-D-lysine powder dissolution in pH value, then in the 1ml phosphate buffer that is 3 in pH value by 0.5g hemocoagulase powder dissolution, and difference fill is in two syringes 410 and 420; The polyurethane powder that weighs 3g weight average molecular weight 5KD is loaded in the 3rd container 30; Configuration coated tool; Pack; Irradiation sterilization;
Application: before use the solid constituent 31 in the 3rd container 30 is dissolved in to the second fluid component 21 in syringe 420, two syringes 410 and 420 front ends install additional injects two kinds of liquid after threeway and nozzle simultaneously it is mixed rapidly at nozzle place, after being sprayed at wound, form gel, final wound closure.
Embodiment 8:
Gel application kit:
1) first fluid component: (pH 9 for the borate buffer of poly-D-lysine (0.6g); 5ml);
2) second fluid component: (pH 5 for phosphate buffer; 5ml), be wherein dissolved with acyclovir (0.1g);
3) solid constituent: PTMC and PLA copolymer (1.5g; Weight average molecular weight 32KD);
4) coated tool: (as shown in Figure 2).
Preparation: the 5ml borate buffer that is first 9 by 0.6g poly-D-lysine powder dissolution in pH value, then in the 5ml phosphate buffer that is 5 in pH value by 0.1g acyclovir powder dissolution, and difference fill is in two syringes 410 and 420; The PTMC and the PLA copolymer powder that weigh 1.5g weight average molecular weight 32KD are loaded in the 3rd container 30; Configuration coated tool; Pack; Irradiation sterilization;
Application: before use the solid constituent 31 in the 3rd container 30 is dissolved in to the second fluid component 21 in syringe 420, two syringes 410 and 420 front ends install additional injects two kinds of liquid after threeway and nozzle simultaneously it is mixed rapidly at nozzle place, after being sprayed at wound, form gel, final wound closure.
Embodiment 9:
Gel application kit:
1) first fluid component: (pH 11 for the borate buffer of poly-D-lysine (0.06g); 2ml);
2) second fluid component: (pH 4.5 for phosphate buffer; 5ml);
3) solid constituent: Polyethylene Glycol multi-branched isomer (1g; Weight average molecular weight 15KD);
4) coated tool: (as shown in Figure 2).
Preparation: the 2ml borate buffer that is first 11 by 0.06g poly-D-lysine powder dissolution in pH value, then the 5ml phosphate buffer that is 4.5 by pH value, fill is in two syringes 410 and 420 respectively; The Polyethylene Glycol multi-branched isomer powder that weighs 1g weight average molecular weight 15KD is loaded in the 3rd container 30; Configuration coated tool; Pack; Irradiation sterilization;
Application: before use the solid constituent 31 in the 3rd container 30 is dissolved in to the second fluid component 21 in syringe 420, simultaneously two syringes 410 and 420 front ends install additional and inject two kinds of liquid after threeway and nozzle simultaneously it is mixed rapidly at nozzle place, after being sprayed at wound, form gel, final wound closure.
Embodiment 10:
Gel application kit:
1) first fluid component: (pH 7 for the borate buffer of poly-D-lysine (0.5g); 5ml);
2) second fluid component: (pH 8 for phosphate buffer; 5ml);
3) solid constituent: polyglycolic acid (5g; Weight average molecular weight 58KD);
4) coated tool: (as shown in Figure 2).
Preparation: the 5ml borate buffer that is first 7 by 0.5g poly-D-lysine powder dissolution in pH value, then the 5ml phosphate buffer that is 8 by pH value, fill is in two syringes 410 and 420 respectively; The polyglycolic acid powder that weighs 5g weight average molecular weight 58KD is loaded in the 3rd container 30; Configuration coated tool; Pack; Irradiation sterilization;
Application: before use the solid constituent 31 in the 3rd container 30 is dissolved in to the second fluid component 21 in syringe 420, two syringes 410 and 420 front ends install additional injects two kinds of liquid after threeway and nozzle simultaneously it is mixed rapidly at nozzle place, after being sprayed at wound, form gel, final wound closure.
Embodiment 11:
Gel application kit:
1) first fluid component: (pH 12 for the borate buffer of poly-D-lysine (1g); 5ml);
2) second fluid component: (pH 11 for phosphate buffer; 5ml), be wherein dissolved with dexamethasone (0.1g) and medical stain (0.1mg);
3) solid constituent: PTMC and PLA copolymer (2g; Weight average molecular weight 12KD);
4) coated tool: (as shown in Figure 2).
Preparation: the 5ml borate buffer that is first 12 by 1g poly-D-lysine powder dissolution in pH value, then 0.1g dexamethasone powder, the medical stain of 0.1mg are dissolved in to pH value is in 11 5ml phosphate buffer, and respectively fill in two syringes 410 and 420; The PTMC and the PLA copolymer powder that weigh 2g weight average molecular weight 12KD are loaded in the 3rd container 30; Configuration coated tool; Pack; Irradiation sterilization;
Application: before use the solid constituent 31 in the 3rd container 30 is dissolved in to the second fluid component 21 in syringe 420, simultaneously two syringes 410 and 420 front ends install additional and inject two kinds of liquid after threeway and nozzle simultaneously it is mixed rapidly at nozzle place, after being sprayed at wound, form gel, final wound closure.
Embodiment 12:
Gel application kit:
1) first fluid component: (pH 10 for the borate buffer of poly-D-lysine (0.01g); 2ml);
2) second fluid component: (pH 3 for phosphate buffer; 5ml), be wherein dissolved with medical stain (0.01mg);
3) solid constituent: Polyethylene Glycol multi-branched isomer (0.5g; Weight average molecular weight 10KD);
4) coated tool: (as shown in Figure 2).
Preparation: the 2ml borate buffer that is first 10 by 0.01g poly-D-lysine powder dissolution in pH value, the more medical stain of 0.01mg is dissolved in to pH value is 3 5ml phosphate buffer, and respectively fill in two syringes 410 and 420; The Polyethylene Glycol multi-branched isomer powder that weighs 0.5g weight average molecular weight 10KD is loaded in the 3rd container 30; Configuration coated tool; Pack; Irradiation sterilization;
Application: before use the solid constituent 31 in the 3rd container 30 is dissolved in to the second fluid component 21 in syringe 420, simultaneously two syringes 410 and 420 front ends install additional and inject two kinds of liquid after threeway and nozzle simultaneously it is mixed rapidly at nozzle place, after being sprayed at wound, form gel, final wound closure.
Embodiment 13:
Gel application kit:
1) first fluid component: (pH 6 for the borate buffer of two polylysines (0.002g); 5ml);
2) second fluid component: (pH 7.3 for phosphate buffer; 5ml), be wherein dissolved with medical stain (0.001mg);
3) solid constituent: gelatin (0.01g) and glutin (3g; Weight average molecular weight 9KD);
4) coated tool: (as shown in Figure 2).
Preparation: first 0.002g dimerization lysine powder is dissolved in to pH value and is 6 5ml borate buffer, the more medical stain of 0.001mg is dissolved in to pH value is in 7.3 5ml phosphate buffer, and respectively fill in two syringes 410 and 420; Weighing 0.01g gelatin powder and 3g weight average molecular weight 9KD glutin powder is loaded in the 3rd container 30; Configuration coated tool; Pack; Irradiation sterilization;
Application: before use the solid constituent 31 in the 3rd container 30 is dissolved in to the second fluid component 21 in syringe 420, two syringes 410 and 420 front ends install additional injects two kinds of liquid after threeway and nozzle simultaneously it is mixed rapidly at nozzle place, after being sprayed at wound, form gel, final wound closure.
Embodiment 14:
Gel application kit:
1) first fluid component: (pH 9 for the borate buffer of poly-D-lysine (0.55g); 5ml);
2) second fluid component: (pH 3.6 for phosphate buffer; 5ml), be wherein dissolved with medical stain (0.1mg);
3) solid constituent: polyglycolic acid (5g; Weight average molecular weight 50KD);
4) coated tool: (as shown in Figure 2).
Preparation: the 5ml borate buffer that is first 9 by 0.55g poly-D-lysine powder dissolution in pH value, the more medical stain of 0.1mg is dissolved in to pH value is in 3.6 5ml phosphate buffer, and respectively fill in two syringes 410 and 420; The polyglycolic acid powder that weighs 5g weight average molecular weight 50KD is loaded in the 3rd container 30; Configuration coated tool; Pack; Irradiation sterilization;
Application: before use the solid constituent 31 in the 3rd container 30 is dissolved in to the second fluid component 21 in syringe 420, two syringes 410 and 420 front ends install additional injects two kinds of liquid after threeway and nozzle simultaneously it is mixed rapidly at nozzle place, after being sprayed at wound, form gel, final wound closure.
Embodiment 15:
Gel application kit:
1) first fluid component: (pH 11 for the borate buffer of poly-D-lysine (0.1g); 3ml);
2) second fluid component: (pH 4 for phosphate buffer; 3ml), be wherein dissolved with medical stain (0.01mg);
3) solid constituent: poly phosphate (1g; Weight average molecular weight 10KD);
4) coated tool: (as shown in Figure 2).
Preparation: the 3ml borate buffer that is first 11 by 0.1g poly-D-lysine powder dissolution in pH value, the more medical stain of 0.01mg is dissolved in to pH value is in 4 3ml phosphate buffer, and respectively fill in two syringes 410 and 420; The poly phosphate powder that weighs 1g weight average molecular weight 10KD is loaded in the 3rd container 30; Configuration coated tool; Pack; Through irradiation sterilization;
Application: before use the solid constituent 31 in the 3rd container 30 is dissolved in to the second fluid component 21 in syringe 420, two syringes 410 and 420 front ends install additional injects two kinds of liquid after threeway and nozzle simultaneously it is mixed rapidly at nozzle place, after being sprayed at wound, form gel, final wound closure.
Embodiment 16:
Gel application kit:
1) first fluid component: (pH 9 for the borate buffer of poly-D-lysine (0.05g); 1ml);
2) second fluid component: (pH 4 for phosphate buffer; 1ml), be wherein dissolved with medical stain (0.001mg);
3) solid constituent: Polyethylene Glycol multiple-limb isomer (0.5g; Weight average molecular weight 20KD);
4) coated tool: (as shown in Figure 2).
Preparation: the 1ml borate buffer that is first 9 by 0.05g poly-D-lysine powder dissolution in pH value, the more medical stain of 0.001mg is dissolved in to pH value is in 4 1ml phosphate buffer, and respectively fill in two syringes 410 and 420; The Polyethylene Glycol multiple-limb isomer powder that weighs 0.5g weight average molecular weight 20KD is loaded in the 3rd container 30; Configuration coated tool; Pack; Irradiation sterilization;
Application: before use the solid constituent 31 in the 3rd container 30 is dissolved in to the second fluid component 21 in syringe 420, two syringes 410 and 420 front ends install additional injects two kinds of liquid after threeway and nozzle simultaneously it is mixed rapidly at nozzle place, after being sprayed at wound, form gel, final wound closure.
Embodiment 17:
Gel application kit:
1) first fluid component: (pH 7 for the borate buffer of poly-D-lysine (0.015g); 1ml);
2) second fluid component: (pH 6 for phosphate buffer; 1ml), be wherein dissolved with medical stain (0.1mg);
3) solid constituent: polyurethane (1g; Weight average molecular weight 15KD);
4) coated tool: (as shown in Figure 2).
Preparation: the 1ml borate buffer that is first 7 by 0.015g poly-D-lysine powder dissolution in pH value, the more medical stain of 0.1mg is dissolved in to pH value is in 6 1ml phosphate buffer, and respectively fill in two syringes 410 and 420; The polyurethane powder that weighs 1g weight average molecular weight 15KD is loaded in the 3rd container 30; Configuration coated tool; Pack; Irradiation sterilization;
Application: before use the solid constituent 31 in the 3rd container 30 is dissolved in to the second fluid component 21 in syringe 420, two syringes 410 and 420 front ends install additional injects two kinds of liquid after threeway and nozzle simultaneously it is mixed rapidly at nozzle place, after being sprayed at wound, form gel, final wound closure.
Embodiment 18:
Gel application kit:
1) first fluid component: (pH 11 for the borate buffer of poly-D-lysine (0.06g); 5ml);
2) second fluid component: (pH 3 for phosphate buffer; 5ml), be wherein dissolved with medical stain (0.01mg);
3) solid constituent: PTMC and PLA copolymer (3.5g; Weight average molecular weight 11KD);
4) coated tool: (as shown in Figure 2).
Preparation: the 5ml borate buffer that is first 11 by 0.06g poly-D-lysine powder dissolution in pH value, the more medical stain of 0.01mg is dissolved in to pH value is in 3 5ml phosphate buffer, and respectively fill in two syringes 410 and 420; The PTMC and the PLA copolymer powder that weigh 3.5g weight average molecular weight 11KD are loaded in the 3rd container 30; Configuration coated tool; Pack; Irradiation sterilization;
Application: before use the solid constituent 31 in the 3rd container 30 is dissolved in to the second fluid component 21 in syringe 420, two syringes 410 and 420 front ends install additional injects two kinds of liquid after threeway and nozzle simultaneously it is mixed rapidly at nozzle place, after being sprayed at wound, form gel, final wound closure.
Embodiment 19:
Gel application kit:
1) first fluid component: (pH 9 for the borate buffer of poly-D-lysine (0.02g); 2ml);
2) second fluid component: (pH 3.5 for phosphate buffer; 5ml), be wherein dissolved with medical stain (0.01mg);
3) solid constituent: Polyethylene Glycol multi-branched isomer (1g; Weight average molecular weight 25KD);
4) coated tool: (as shown in Figure 2).
Preparation: the 2ml borate buffer that is first 9 by 0.02g poly-D-lysine powder dissolution in pH value, the more medical stain of 0.01mg is dissolved in to pH value is 3.5 5ml phosphate buffer, and respectively fill in two syringes 410 and 420; The Polyethylene Glycol multi-branched isomer powder that weighs 1g weight average molecular weight 25KD is loaded in the 3rd container 30; Configuration coated tool; Pack; Irradiation sterilization;
Application: before use the solid constituent 31 in the 3rd container 30 is dissolved in to the second fluid component 21 in syringe 420, simultaneously two syringes 410 and 420 front ends install additional and inject two kinds of liquid after threeway and nozzle simultaneously it is mixed rapidly at nozzle place, after being sprayed at wound, form gel, final wound closure.
Embodiment 20:
Gel application kit:
1) first fluid component: (pH 10 for the borate buffer of poly-D-lysine (0.005g); 5ml);
2) second fluid component: (pH 4 for phosphate buffer; 5ml), be wherein dissolved with medical stain (0.01mg);
3) solid constituent: polyglycolic acid (1g; Weight average molecular weight 18KD);
4) coated tool: (as shown in Figure 2).
Preparation: the 5ml borate buffer that is first 10 by 0.005g poly-D-lysine powder dissolution in pH value, the more medical stain of 0.01mg is dissolved in to pH value is in 4 5ml phosphate buffer, and respectively fill in two syringes 410 and 420; The polyglycolic acid powder that weighs 1g weight average molecular weight 18KD is loaded in the 3rd container 30; Configuration coated tool; Pack; Irradiation sterilization;
Application: before use the solid constituent 31 in the 3rd container 30 is dissolved in to the second fluid component 21 in syringe 420, two syringes 410 and 420 front ends install additional injects two kinds of liquid after threeway and nozzle simultaneously it is mixed rapidly at nozzle place, after being sprayed at wound, form gel, final wound closure.
Claims (14)
1. the gel application kit that can prevent cerebrospinal fluid seepage after spinal surgery, described external member comprises:
A) the first fluid component in the first container of sealing, described first fluid component comprises that it is the solution forming in the first buffer solution between 3 to 12 that the lysine compounds of the group of selecting free lysine, two polylysines, poly-D-lysine and combination composition thereof is dissolved in pH value;
B) the second fluid component in the second container of sealing, described second fluid component is that pH value is the second buffer solution between 3 to 12;
C) solid constituent in the 3rd container of sealing, described solid constituent comprises medical macromolecular materials, the group that described medical macromolecular materials select free PTMC, polylactic acid, Polyethylene Glycol, the isomer of Polyethylene Glycol multi-branched, glutin, polyurethane, gelatin, poly phosphate, polyglycolic acid and copolymer thereof and blend to form, and described medical macromolecular materials have with 1% concentration be dissolved in the chloroform solvent of 25 ℃, with Ubbelohde viscometer, record 0.01 to the intrinsic viscosity in the scope of 5dl/g; And
D) coating tool;
And,
Described first fluid component, described second fluid component and described solid constituent form the formula of described gel application kit, and in the gross weight of described formula, the percentage by weight of described lysine compounds is 0.1%～30%; The percentage by weight of described medical macromolecular materials is 1%-70%; Volume ratio between described first fluid component and described second fluid component is from 30:70 to 70:30; And, when described first fluid component, described second fluid component and described solid constituent are mixed, jointly form gel.
2. gel application kit as claimed in claim 1, wherein, described intrinsic viscosity 0.05 in the scope of 0.2dl/g.
3. gel application kit as claimed in claim 1, wherein, in the gross weight of described formula, the percentage by weight of described lysine compounds is 0.1%～10%.
4. gel application kit as claimed in claim 1, wherein, the volume ratio between described first fluid component and described second fluid component is from 40:60 to 60:40.
5. gel application kit as claimed in claim 1, wherein, the volume ratio between described first fluid component and described second fluid component is from 45:55 to 55:45.
6. gel application kit as claimed in claim 1, wherein, described the first buffer solution and the second buffer solution are selected from phosphate buffer solution and borate buffer solution independently of one another.
7. gel application kit as claimed in claim 1, wherein, described the first buffer solution is that pH6 is to 12 borate buffers; The phosphate buffer solution that described the second buffer solution is pH3 to 11.
8. gel application kit as claimed in claim 1, the weight average molecular weight of wherein said medical macromolecular materials is in 1000 to 300,000 daltonian scopes.
9. gel application kit as claimed in claim 8, the weight average molecular weight of wherein said medical macromolecular materials is in 2000 to 50,000 daltonian scopes.
10. gel application kit as claimed in claim 1, wherein said first fluid component, described second fluid component or described solid constituent one or more of also comprise select free haemostatic medicament, alleviate cellular edema medicine, the medicine of group that antibiotic medicine, antiviral drugs and combination thereof form, and, in the gross weight of described formula, described drug weight percentage ratio is 0.01%～20%.
11. gel application kit as claimed in claim 10, wherein said haemostatic medicament is selected from tranexamic acid and hemocoagulase; The described cellular edema medicine that alleviates is aescine; Described antibiotic medicine is selected from penicillin, cephalosporin, vancomycin, tobramycin, amikacin, gentamycin and dexamethasone; Described antiviral drugs is selected from virazole, acyclovir and ganciclovir.
12. gel application kit as claimed in claim 1, wherein said solid constituent is the powder of homogeneous.
13. gel application kit as claimed in claim 1, one or more of in wherein said first fluid component, described second fluid component and described solid constituent also comprise medical stain, and, in the gross weight of described formula, the percetage by weight of described medical stain is 1:100～10:100.
14. gel application kit as claimed in claim 1, wherein said coating tool is used for forming after macromolecular material fluid the described solid constituent in described the 3rd container being dissolved into second fluid component in described second container, the described macromolecular material fluid in the first fluid component in described the first container and described second container is mixed to the position that is coated to cerebrospinal fluid seepage after described spinal surgery.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201010253842.XA CN101961504B (en) | 2010-08-13 | 2010-08-13 | Gel coating accessory capable of preventing spinal surgery cerebrospinal fluid leakage |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201010253842.XA CN101961504B (en) | 2010-08-13 | 2010-08-13 | Gel coating accessory capable of preventing spinal surgery cerebrospinal fluid leakage |
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| Publication Number | Publication Date |
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| CN101961504A CN101961504A (en) | 2011-02-02 |
| CN101961504B true CN101961504B (en) | 2014-03-19 |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101249274A (en) * | 2008-04-01 | 2008-08-27 | 南京大学 | Preparation of bletilla striata polyose water gelatin of promoting wound healing and uses thereof |
| CN101524560A (en) * | 2007-03-05 | 2009-09-09 | 综合性外科公司 | Low swelling biocompatibility hydrogel |
| CN101745138A (en) * | 2010-01-09 | 2010-06-23 | 褚加冕 | Dressing preparation method of antibacterial amorphous hydrogel based on biological properties |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101524560A (en) * | 2007-03-05 | 2009-09-09 | 综合性外科公司 | Low swelling biocompatibility hydrogel |
| CN101249274A (en) * | 2008-04-01 | 2008-08-27 | 南京大学 | Preparation of bletilla striata polyose water gelatin of promoting wound healing and uses thereof |
| CN101745138A (en) * | 2010-01-09 | 2010-06-23 | 褚加冕 | Dressing preparation method of antibacterial amorphous hydrogel based on biological properties |
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