CN102274067B - Manufacturing method of developable inflatable balloon for kyphoplasty - Google Patents
Manufacturing method of developable inflatable balloon for kyphoplasty Download PDFInfo
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- CN102274067B CN102274067B CN 201110107501 CN201110107501A CN102274067B CN 102274067 B CN102274067 B CN 102274067B CN 201110107501 CN201110107501 CN 201110107501 CN 201110107501 A CN201110107501 A CN 201110107501A CN 102274067 B CN102274067 B CN 102274067B
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Abstract
The invention relates to a developable inflatable balloon for kyphoplasty and a manufacturing method thereof. Developable polyurethanes are used as raw materials for the balloon, and developable polyurethane particles are fused and mixed and then are extruded to form a balloon tubing. Then the developable inflatable balloon is obtained by blow molding of the balloon tubing. The balloon of the invention not only has excellent biocompatibility and safety, but also can be developed in vivo. The developable inflatable balloon can be applied to vertebra balloon catheters and to treatment of vertebral compression fractures and osteoporosis, so as to enable surgeon doctors to accurately determine the location and the size of the balloon in the inflating process. Therefore, the vertebra height is restored to the greatest extent, the problem of poor balloon development of vertebra balloon catheters during the surgery is solved, and the surgery quality is guaranteed. The developable inflatable balloon and the manufacturing method thereof of the invention have wide clinic application prospects.
Description
Technical field
The present invention relates to a kind of balloon kyphoplasty with the balloon-expandable and preparation method thereof that can develop, belong to medical instruments field.
Background technology
Balloon kyphoplasty is a kind of Minimally Invasive Surgery.Under monitoring, first guide pin is inserted vertebral body, then insert the trocar with wire, with drill bit needle track being extended to enough balloon-expandables passes through, insert the balloon-expandable of vertebral body catheter-balloon to the below of affected part collapse of vertebra soleplate side, under pressure and x-ray monitoring, give the balloon-expandable inflatable dilatation, balloon-expandable is expanded to the cortical bone Edge-stopping and inflates, and makes the vertebral body of subsiding recover height.Be in harmonious proportion bone cement, bone cement sucked infusion appliance, bubble is discharged, under monitoring, bone cement is slowly injected vertebral body, when charging quantity reach vertebral body 2/3 or stop injection during to the edge of vertebral body cortical bone, stabilizing spine effectively after bone cement solidifies.
There is the shortcoming of following aspect in this balloon-expandable: the balloon-expandable in the existing vertebral body foley's tube only develops by the becket of two X-ray opaques on the balloon-expandable inner tube, and in vertebral body inflation process, can't see position and the size of inflation, exist the balloon-expandable development of vertebral body catheter-balloon poor, affect the problem that operative doctor is accurately judged the balloon-expandable position.
It is good that polyurethane material has mechanical property, avirulence, and the advantages such as easy-formation processing especially have good biology performance, use more and more extensive at biomedical sector.But only contain the low electron density such as C, H, O, N and low-gravity element in the polyurethane structural and can not be by the X-ray detection, existing several different methods is used for improving polyurethane the resistance of X-ray is penetrated performance to improve development effect at present.Wherein the simplest method be with blend such as polymer and heavy metal inorganic salt, powders, but this physical blending method is easy to cause material property decline, thereby has limited the application of polyurethane developing material.If obtain stable developing polyurethane material, the form of the elements such as iodine by chemical bond is incorporated in the polyurethane material, be a kind of effective method.
Summary of the invention
The object of the present invention is to provide a kind of balloon kyphoplasty with the balloon-expandable that can develop, by selecting the micromolecule that contains iodine as chain extender, the halogen atom that will have development is incorporated in the polyurethane chain structure, the employing polyurethane that can develop prepares sacculus, thereby makes sacculus have safe and effective and the characteristics of development are arranged.
Second purpose of the present invention is to provide a kind of preparation method of formula balloon kyphoplasty with the balloon-expandable that can develop of developing.
Balloon kyphoplasty of the present invention can develop polyurethane as balloon material with the balloon-expandable that can develop, employing.
The described polyurethane that develops is by oligomer dihydroxylic alcohols and di-isocyanate reaction are obtained base polyurethane prepolymer for use as, the chain extender that contains halogens in the rear adding strand, the halogen group in the chain extender link together by chemical b ` and base polyurethane prepolymer for use as and make.Owing to having the halogen that can develop in the chain extender, so that the polyurethane of making has long-acting development effect.
The balloon kyphoplasty of the present invention preparation method of the balloon-expandable that can develop comprises:
(a) urethane raw that can develop joins in the extruder, extrudes pipe, and cooling and shaping becomes sacculus with pipe;
(b) described sacculus is placed the convergent divergent channel mould with pipe, mould is closed, and clamping mold and energising heat up, and pass into compressed air or nitrogen inflation pipe balling-up capsule convergent divergent channel;
(c) described ball-bag dilation tube is placed again another sacculus mould ventilation heating, making the ball-bag dilation tube inflation is described balloon kyphoplasty balloon-expandable, and wherein said sacculus mould internal diameter is greater than the internal diameter of the used convergent divergent channel mould of step b.
According to the present invention, the extrusion condition of the extruder among the described step a is: extruder barrel feeding section temperature is 170 ℃～190 ℃, and the compression section temperature is 180 ℃～190 ℃, and the metering section temperature is 180 ℃～190 ℃, 180 ℃～190 ℃ at head position; Screw speed 10～15r/min, hauling speed is 500～600cm/min, 25～35 ℃ of cooling water temperatures.Preferably, the extrusion condition of the extruder among the described step a is: extruder barrel feeding section temperature is 175 ℃～185 ℃, and the compression section temperature is 180 ℃～190 ℃, and the metering section temperature is 180 ℃～190 ℃, 180 ℃～190 ℃ at head position; Screw speed 10～12r/min, hauling speed is 550～600cm/min, 30 ℃ of cooling water temperatures.
According to the present invention, be warming up to 175～190 ℃ among the described step b.
According to the present invention, ventilation described in the described step c is heated to 110～140 ℃.
The present invention has following outstanding beneficial effect:
The present invention is owing to being incorporated into the development element in the polyurethane chain structure by chemical bond, therefore have long-acting development effect, development effect is good, has simultaneously good biocompatibility and safety, good cell compatibility is a kind of balloon material of function admirable; Cheap, can be used for treating the syndromes such as collapse of vertebra, fracture.
Also there is not in the market the vertebral body catheter-balloon that can develop, only lean on the becket of two X-ray opaques on the balloon-expandable inner tube to develop in doctor's operating process, and in vertebral body inflation process, can't see position and the size of inflation, so that inflation is excessive, the vertebral body cavity that forms increases thereupon, and the bone cement loading is too much, causes the seepage of bone cement, reduced the safety of operation, thus the effect of impact operation.Also have because can not the developing of sacculus, the doctor is in the dilation procedure process, and inflation is too small, and the vertebral body cavity ratio volume of ideal of formation is little, and vertebral body can not return to normal height; The bone cement loading is few simultaneously, and vertebral body intensity recovery effects is poor, the effect of impact operation.Balloon-expandable of the present invention is mainly used in the vertebral body foley's tube in the balloon kyphoplasty, this production is simple, the development property of balloon material so that sacculus can at utmost expand, thereby allow the vertebral height that subsides farthest recover, the vertebral height recovery effects is better than common vertebral body foley's tube, has wide potential applicability in clinical practice.
Description of drawings
Fig. 1 is convergent divergent channel mould cross-sectional view.
Fig. 2 is the sacculus mould cross-sectional view.
Fig. 3 is sacculus shape schematic diagram.
Fig. 4 is RQ13 vertebral body foley's tube structural representation.
The specific embodiment
Below in conjunction with specific embodiment, further set forth the present invention.Should be understood that these embodiment only to be used for explanation the present invention and be not used in and limit the scope of the invention.
The experimental technique of unreceipted actual conditions in the following example, usually according to normal condition, or the condition of advising according to manufacturer.
Be that 1500 poly-(carbonic acid 1,6-hexanediol) esterdiol and 4 ' 4-methyl diphenylene diisocyanate mix with the molecular weight of processed in advance, mol ratio is 0.39: 1, N
2Protect lower 80 ℃ of stirring reactions 2.5 hours, obtain prepolymer, be warming up to 90 ℃, add the chain extender N of melting; N-dihydroxy ethyl paraiodoaniline, chain extender and vulcabond mol ratio are 0.3: 1, stir 20min; 75 ℃ of plasticizing 5h obtain developing polyurethane after the discharging, and hardness is 90A.
With hardness be the developed polyurethane of 90A after 50 ℃ of lower vacuum drying 4-5 hours, join in the extruder, extrude that to be processed into internal diameter be 2mm, external diameter is transparent, smooth surface, the even balloon tube of bubble-free wall thickness of 3mm.Extrusion condition is: 175 ℃ of extruder barrel feeding section temperature, 180 ℃ of compression section temperature, 180 ℃ of metering section temperature, 180 ℃ at head position; Screw speed 12r/min, hauling speed is 600cm/min, 30 ℃ of cooling water temperatures.
It is 10mm that balloon tube is placed on diameter shown in Figure 1, and length is in the cavity of convergent divergent channel mould 10 of 20mm, and mould is closed, and the energising heating makes mould be warming up to 180 ℃, passes into nitrogen to 10kg/cm in the time of intensification in pipe
2, pipe is blown into the dilating sacculus pipe, stopped heating, cooling; The dilating sacculus pipe being placed internal diameter shown in Figure 2 is in the cavity of sacculus mould 20 of 20mm again, pass into nitrogen, heated air to 120 ℃, making the convergent divergent channel inflation that closes in the mould is required form, after sacculus forms, and the demoulding, namely make diameter 20mm, length 30mm, the RQ13 vertebral body foley's tube of compressive resistance 30atm sacculus 1, shape is as shown in Figure 3.
Be that 2000 PTMG and 4 ' 4-methyl diphenylene diisocyanate mix with the molecular weight of processed in advance, mol ratio is 0.5: 1, N
2Protect lower 80 ℃ of stirring reactions 2 hours, obtain prepolymer, be warming up to 85 ℃, add the chain extender N of melting; N-dihydroxy ethyl paraiodoaniline, chain extender and vulcabond mol ratio are 0.2: 1, stir 10min; 75 ℃ of plasticizing 5h obtain developing polyurethane after the discharging, and hardness is 80A.
With hardness be the developed polyurethane of 80A after 50 ℃ of lower vacuum drying 4-5 hours, join in the extruder, extrude that to be processed into internal diameter be 2.5mm, external diameter is that transparent, the smooth surface, the even sacculus of bubble-free wall thickness of 3.5mm is with pipe.Extrusion condition is: 185 ℃ of extruder barrel feeding section temperature, 190 ℃ of compression section temperature, 190 ℃ of metering section temperature, 190 ℃ at head position; Screw speed 10r/min, hauling speed is 550cm/min, 30 ℃ of cooling water temperatures.
It is 15mm that balloon tube is placed on diameter shown in Figure 1, and length is in the cavity of convergent divergent channel mould 10 of 20mm, and mould is closed, and the energising heating makes mould be warming up to 185 ℃, passes into nitrogen to 22kg/cm in the time of intensification in pipe
2, pipe is blown into the dilating sacculus pipe, stopped heating, cooling; The dilating sacculus pipe being placed internal diameter shown in Figure 2 is in the sacculus mould 20 of 25mm again, pass into nitrogen, heated air to 130 ℃, making the convergent divergent channel inflation that closes in the mould is required form, after sacculus forms, and the demoulding, namely make diameter 25mm, length 25mm, the RQ13 vertebral body foley's tube of compressive resistance 28atm sacculus 1, shape is as shown in Figure 3.
As shown in Figure 4, RQ13 vertebral body foley's tube is comprised of Y type head 3, main pipe 2, sacculus 1, core pipe 4, concrete assembling is as follows: be the 4 lower end sealing-ins of 1.9mm core pipe with sacculus 1 lower end and external diameter, internal diameter is sacculus 1 upper end of 2.2mm and the main pipe 2 lower end sealing-ins that external diameter is 2.1mm, main pipe 2 upper ends are connected with Y type head 3 after being inserted in protecting pipe, the seal wire of packing in the core pipe 4 with nut places in the Y type head 3, and assembling is finished.
During operation, the patient is prostrate, determines the body surface projection of sick vertebra pedicle of vertebral arch in C type arm X-ray machine monitoring, and percutaneous inserts the localised puncture needle cannula from the outer upper limb of pedicle of vertebral arch body surface projection, and with drill bit needle track is extended to enough balloon-expandables and passes through, and sets up service aisle; Insert the developed dilatation balloon of RQ13 vertebral body catheter-balloon to the below of affected part collapse of vertebra soleplate side, to balloon-expandable pressurization expansion, development property and C type arm Real-Time Monitoring sacculus position and size and shape by sacculus, the development property of sacculus can help the doctor to control balloon-expandable and be expanded to the cortical bone edge, stop to inflate, make the vertebral body of subsiding at utmost recover height.Be in harmonious proportion bone cement, bone cement sucked infusion appliance, bubble is discharged, under monitoring, bone cement is slowly injected vertebral body, when charging quantity reach vertebral body 2/3 or stop injection during to the edge of vertebral body cortical bone.The bone cement seepage does not appear in the art; The salient angle degree is 15.7 ° after the front anterior vertebral of art, and postoperative is 5.2 °, and kyphosis deformity is improved as 10.5 °; Patient's pain is obviously alleviated.
And present clinically sacculus, because balloon material does not have development, can only control according to doctor's operating experience the degrees of expansion of sacculus in the actual use procedure, namely the degree of raising of collapse of vertebra height, usually salient angle degree deformity is improved as about 6 degree behind the postoperative, is difficult to reach 10 degree.Production of the present invention is simple, the development property of balloon material so that sacculus can at utmost expand, thereby allow the vertebral height that subsides farthest recover, the vertebral height recovery effects is better than common vertebral body foley's tube, has wide potential applicability in clinical practice.
Claims (1)
1. a balloon kyphoplasty is characterized in that with the preparation method of the balloon-expandable that can develop, and comprising:
(a) urethane raw that can develop joins in the extruder, extrude pipe, cooling and shaping becomes sacculus with managing, the extrusion condition of described extruder is: extruder barrel feeding section temperature is 170 ℃～190 ℃, the compression section temperature is 180 ℃～190 ℃, the metering section temperature is 180 ℃～190 ℃, 180 ℃～190 ℃ at head position; Screw speed 10～15r/min, hauling speed is 500～600cm/min, 25 ℃～35 ℃ of cooling water temperatures;
(b) described sacculus is placed the convergent divergent channel mould with pipe, mould is closed, and clamping mold and energising are warming up to 175～190 ℃, pass into compressed air or nitrogen inflation pipe balling-up capsule convergent divergent channel;
(c) described ball-bag dilation tube is placed again the sacculus mould ventilation be heated to 110～140 ℃, to make the ball-bag dilation tube inflation be described balloon kyphoplasty with the balloon-expandable that can develop, and wherein said sacculus mould internal diameter is greater than the internal diameter of the used convergent divergent channel mould of step (b).
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| Application Number | Priority Date | Filing Date | Title |
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| CN 201110107501 CN102274067B (en) | 2011-04-26 | 2011-04-26 | Manufacturing method of developable inflatable balloon for kyphoplasty |
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| CN 201110107501 CN102274067B (en) | 2011-04-26 | 2011-04-26 | Manufacturing method of developable inflatable balloon for kyphoplasty |
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| CN102274067A CN102274067A (en) | 2011-12-14 |
| CN102274067B true CN102274067B (en) | 2013-01-23 |
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Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102805661A (en) * | 2012-09-04 | 2012-12-05 | 上海朗迈医疗器械科技有限公司 | Balloon dilator used for treating vertebral body compression fracture |
| CN110975112B (en) * | 2019-12-17 | 2022-02-08 | 禾木（中国）生物工程有限公司 | Preparation method of balloon catheter |
| CN112402772A (en) * | 2020-12-09 | 2021-02-26 | 威高奋威健康科技发展(上海)有限公司 | Vertebral body expansion device and manufacturing method thereof |
| CN114261080A (en) * | 2021-12-16 | 2022-04-01 | 科睿驰（深圳）医疗科技发展有限公司 | Balloon forming method |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101392048A (en) * | 2008-09-27 | 2009-03-25 | 清华大学 | Method for preparing developing polyurethane |
| CN201469385U (en) * | 2009-08-25 | 2010-05-19 | 北京众合赛福医疗科技发展有限公司 | Integrated structural outer tube and saccule |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US20050209629A1 (en) * | 2001-04-19 | 2005-09-22 | Kerr Sean H | Resorbable containment device and process for making and using same |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101392048A (en) * | 2008-09-27 | 2009-03-25 | 清华大学 | Method for preparing developing polyurethane |
| CN201469385U (en) * | 2009-08-25 | 2010-05-19 | 北京众合赛福医疗科技发展有限公司 | Integrated structural outer tube and saccule |
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