The preparation method of sacculus, sacculus dilating catheter and sacculusTechnical field
The present invention relates to technical field of medical instruments, more particularly to a kind of sacculus, sacculus dilating catheter and sacculusPreparation method.
Background technology
In recent ten years, with the aggravation and the rising of onset diabetes rate of China human mortality aging, heart and brain bloodPipe and peripheral vascular illness rate also constantly rise.In vascular diseases, arteries is narrow directly to jeopardize diseaseThe life security of people.The seventies in last century, balloon expanding technology is occurred in that, it is in medical imaging deviceUnder guiding, foley's tube is inserted the narrow positions of blood vessel with Percutaneous Techniques, carried out under strict monitoringBalloon expandable expands, and is expanded the narrow positions of blood vessel, so as to recover lumen diameter, this method withTraditional surgery is compared, and only needs local anaesthesia, opens the osculum of 1-2mm, with bleeding is few, woundThe advantages of small, few intercurrent disease, post-operative recovery are fast and safe and reliable, can significantly mitigate the pain that patient is bornIt is bitter.And, sacculus dilating catheter treatment has repeatability, after there is reangiostenosis, can also lead toMinimally invasive method is crossed to expand again.Even if in addition, operative failure, it is to further support or vascular bypassOperation does not have significant impact, therefore, interventional therapy operation is good with its minimally invasive, repeatable operation, curative effectThe advantages of be increasingly becoming the treatment narrow means of arteries of first-selection.
Existing sacculus dilating catheter needs contrast agent and is socketed on aobvious on the outside of sacculus for the positioning of sacculusShadow marks to aid in completing, and the positioning time of contrast agent is shorter, and developing mark is determined by relative distanceThe position of position sacculus, the relative position for various sizes of sacculus setting developing mark is different, thereforeThen it is more difficult to estimate sacculus physical location for the sacculus of single developing mark.Additionally, being socketed with the ball of developing markCapsule often has larger external diameter value at developing mark, it is more difficult to pass through tortuous stenotic lesion.
For the problems of existing sacculus dilating catheter, those skilled in the art always search for solvingMethod.
The content of the invention
It is an object of the invention to provide the preparation method of a kind of sacculus, sacculus dilating catheter and sacculus, with gramTake sacculus dilating catheter of the prior art and use contrast agent and development mark to meet the demand of sacculus positioningDefect existing for note auxiliary completion.
In order to solve the above technical problems, the present invention provides a kind of sacculus, the sacculus includes the tapered portion at two endsWith middle flat part, the sacculus has autography performance.The autography performance of sacculus of the present invention isRefer to that sacculus has developability in itself, it is not necessary to extra that development positioning is carried out to sacculus using development point or developer.
Optionally, in described sacculus, the material for preparing the sacculus includes developing material.
Optionally, in described sacculus, the developing material be BaSO4, Bi2O3, (BiO) 2CO3,One or more in BiOCL, W, WC of blend.
Optionally, in described sacculus, prepare the material of the sacculus also include TPU, Nylon, PE,One or more in Pebax, PET of blend.
Optionally, in described sacculus, the developing material accounts for the mass ratio of the material for preparing the sacculusIt is 10%~60%.
Optionally, in described sacculus, it is Pebax and (BiO) 2CO3, institute to prepare the material of the sacculusThe mass ratio for stating Pebax and (BiO) 2CO3 is 70：30.
Optionally, in described sacculus, the material of the sacculus is prepared for Pebax and BiOCL, it is describedThe mass ratio of Pebax and BiOCL is 60：40.
The present invention provides a kind of sacculus dilating catheter, and the sacculus dilating catheter includes：Inner tube, outer tube and useIn the connector of connection induction system, wherein said inner tube is placed in the outer tube, the near-end of the outer tubeIt is connected with the connector, it is characterised in that also including sacculus as described above, the distal end quilt of the sacculusThe outside of the distal end of said inner tube is fixed on, the near-end of the sacculus is connected with the distal end of the outer tube.
The present invention also provides a kind of preparation method of sacculus, and the preparation method of the sacculus includes：
Original tube is made using the intermingling material comprising developing material；
The original tube is put into the sacculus is made in sacculus mould.
Optionally, in the preparation method of described sacculus, by extruding-out process or blow moulding processIt is made original tube.
Optionally, in the preparation method of described sacculus, the developing material be BaSO4, Bi2O3,(BiO) blend of one or more in 2CO3, BiOCL, W, WC.
Optionally, in the preparation method of described sacculus, prepare the material of the sacculus also include TPU,One or more in Nylon, PE, Pebax, PET of blend.
Optionally, in the preparation method of described sacculus, the developing material accounts for the material for preparing the sacculusThe mass ratio of material is 10%~60%.
In the preparation method of sacculus provided by the present invention, sacculus dilating catheter and sacculus, the sacculus bagThe tapered portion at two ends and the flat part of centre are included, is designed by the raw material for preparing sacculus so that systemThe sacculus made has autography performance, without additionally setting developing mark or using developer, you can obtain ballThe physical location of capsule, while so that there is sacculus dilating catheter the smaller external diameter that passes through to pass through circuitous with more excellentThe ability of bent lesion so that doctor is more handy in surgical procedure.
Brief description of the drawings
Fig. 1 is the generalized section of sacculus in one embodiment of the invention；
Fig. 2 is the flow chart of the preparation method of the sacculus of one embodiment of the invention；
Fig. 3 is the fragmentary, perspective view of sacculus dilating catheter in one embodiment of the invention.
In figure, sacculus -110；Tapered portion -111；Flat part -112；Sacculus pipeline section -113；Inner tube -120；OutwardPipe -130；Connector -140.
Specific embodiment
Below in conjunction with the drawings and specific embodiments to sacculus proposed by the present invention, sacculus dilating catheter and sacculusPreparation method is described in further detail.According to following explanation and claims, advantages of the present invention and spyLevying to become apparent from.It should be noted that, accompanying drawing using very simplify in the form of and use non-accurately ratio,Only it is used to conveniently, lucidly aid in illustrating the purpose of the embodiment of the present invention.
Core concept of the invention is, there is provided the preparation method of a kind of sacculus, sacculus dilating catheter and sacculus,By to sacculus raw material Modification design so that the sacculus of preparation has autography performance, and then based on certainly aobviousThe sacculus of shadow performance assemble and obtains the sacculus dilating catheter with development effect, it is therefore not necessary to additionally setDeveloping mark is put, you can obtain the physical location of sacculus, while so that sacculus dilating catheter has smaller wearingMore external diameter and the more excellent ability for passing through tortuous lesion, mitigate pain of the patient in surgical procedure so thatDoctor is more handy in surgical procedure.
Fig. 1 is refer to, it is the generalized section of sacculus in one embodiment of the invention, as shown in figure 1, describedThe tapered portion 111 of sacculus 110 including two ends and the flat part 112 of centre, with described in the two ends of sacculus 110 graduallyThe sacculus pipeline section 113 that contracting portion 111 connects respectively；Wherein, the sacculus 110 has autography performance.HereThe sacculus there is autography performance to refer to sacculus there is developability in itself, gold is set without extraCategory development point carries out development positioning using developer.Wherein, preparing the material of the sacculus 110 includes showingShadow material, the developing material is BaSO4、Bi2O3、(BiO)2CO3, in BiOCL, W, WC onePlant or various blends；Additionally, prepare the material of the sacculus 110 also include TPU, Nylon, PE,One or more in Pebax, PET of blend.
In the present embodiment, by one kind in developing material and TPU, Nylon, PE, Pebax, PET or manyThe blend planted is mixed according to predetermined ratio (prepares institute to be made the intermingling material with developing performanceState the material of sacculus).In fact, with the continuous rising of developing material ratio, preparing the sacculus 110The development capability of material is constantly lifted, and prepares the mechanical performance (mechanicalness here of the material of the sacculus 110Rigidity can be referred specifically to) there is certain rising, but the rising of mechanical performance can cause the difficulty that sacculus 110 is moldedIncrease and the pliability after the shaping of sacculus 110 has declined.Therefore, it is according to system when predetermined ratio is selectedThe shaping of standby sacculus 110 and development effect consider setting.It is same by the multiple research experiment of inventorWhen comprehensively consider sacculus needed for property indices after verify find, prepare the sacculus when developing material is accounted forWhen the mass ratio of 110 material is less than 10%, the development effect of the sacculus 110 of preparation is not good, when development materialWhen material accounts for the mass ratio of the material for preparing the sacculus 110 more than 60%, the more difficult shaping of sacculus 110, andThe performance of sacculus 110 after shaping is not good, therefore, preferred developing material is preparing the sacculus in the present embodimentShared mass ratio is 10%~60% in 110 material.Because developability presence is poor between different developing materialsDifferent, the ratio accounted for for developing material in the material for preparing the sacculus 110 can be with difference, as long as meeting mostThe shaping of end bulb capsule 110 and the demand of development effect.
Further, under normality, the outline of the cross section of the tapered portion 111 and/or flat part 112 isPolygon or circle.When the sacculus 110 is expanded, the tapered portion 111 at the two ends of the sacculus 110Be round platform or many rib round platforms, the flat part 112 is polygon prism or cylinder, the sacculus 110 it is straightThe diameter range in portion 112 is 0.6mm~40.0mm, and the length range of the flat part 112 is5.0mm~280.0mm.
Fig. 2 is refer to, it is the flow chart of the preparation method of the sacculus of one embodiment of the invention.As shown in Fig. 2
First, step S1 is performed, original tube is made using the intermingling material comprising developing material；
Specifically, configuration prepare the sacculus needed for intermingling material, by extruding-out process or be blow molded intoType technique by the intermingling material extrude or blow molding be tubulose as original tube；Wherein, it is described commonMixed material includes the blending of one or more in developing material and TPU, Nylon, PE, Pebax, PETThing.Wherein, the proportion that the developing material accounts for the intermingling material is 10%~60%；The developmentMaterial is BaSO4、Bi2O3、(BiO)2CO3, one or more in BiOCL, W, WC of blend；The material for preparing is
Then, step S2 is performed, the original tube is put into the sacculus is made in sacculus mould.
Specifically, original tube is put into sacculus mould, one end of original tube is passed through high pressure nitrogen,The other end is closed, and original tube is heated into uniform temperature, and two ends impose the pulling force of setting, with the drawing for settingStretch speed tensile certain distance, after shaping obtains 112 points of the flat part of sacculus, then carry out succeeding stretch and obtainThe tapered portion 111 of sacculus and sacculus pipeline section 113.Carried out under sacculus finally is placed in into higher temperature and certain pressureSizing, leads to recirculated cooling water and is cooled down afterwards, sacculus is taken out from sacculus mould, with autographyThe sacculus of performance is prepared and completed.
Fig. 3 is refer to, it is the fragmentary, perspective view of sacculus dilating catheter in one embodiment of the invention.Such as Fig. 3 institutesShow, the sacculus dilating catheter include sacculus as described above 110, inner tube 120, outer tube 130 and for evenThe connector 140 of induction system is connect, wherein said inner tube 120 is placed in the outer tube 130, the outer tube130 one end is connected with the connector 140, and one end of the sacculus 110 is fixed in said inner tube 120Outside, the other end of the sacculus 110 is connected with the outer tube 130, and the sacculus 110 has from aobviousShadow performance.
, it is necessary to the sacculus of autography performance assemble had after the sacculus with autography performance is preparedThere is the sacculus dilating catheter of development effect, detailed process is as follows：
To the near-end of sacculus, (near-end here is proximate to operation respectively after the sacculus heat treatment a period of time that will be preparedOne end of operating side, distal end is remote from the one end at operation technique end) laser welding is carried out with the distal end of sacculus,So that the distal end of the inner tube 120 of sacculus dilating catheter is welded with the distal end of sacculus, near-end and the sacculus of sacculus expandThe distal end welding of the outer tube 130 of conduit is opened, by outer tube 130 proximally by medical grade glue and connector 140Bonding, so as to prepare the sacculus dilating catheter with developing function.For convenience of operating, can be in sacculusBe proximally and distally provided with inner tube 120 and outer tube 130 that sacculus pipeline section is respectively used to sacculus dilating catheterWelding.Wherein, the profile of sacculus is controlled by the shape of the inner chamber of sacculus mould, sacculus is being madeDuring dilating catheter, sacculus is folded into three wings or multiple wing form according to polygonal side number.Carried out when to sacculusDuring low pressure pressurising, under low-pressure state (i.e. normality), balloon expandable is circular or many into the outline of cross sectionThe state of side shape, as pressure is gradually increased to operating pressure, balloon expandable glomeration sacculus body, so as toVascular wall matches.When sacculus pressure release is withdrawn from, sacculus revert to before folding three wings or multiple wing form,Resistance is withdrawn so as to reduce, it is to avoid frictionally damage is caused to vascular wall, to avoid the generation of vascular complication.The folding restorability of sacculus of the invention is reliable and stable.
In order to be better understood from preparing the detailed process of sacculus dilating catheter, two specific implementations are set forth belowExample is explained in detail.
Embodiment one：1.50mm*20.0mm (length of the flat part of the diameter * sacculus of the flat part of sacculus)The preparation of development sacculus dilating catheter
By blending ratio Pebax70D：(BiO)2CO3=70：30 intermingling material extrudes chi by extrusion equipmentVery little is the original tube of 0.0205inch*0.0105inch (OD*ID), and wherein OD is the external diameter of original tube,ID is the internal diameter of original tube, and it is the straight mould of 21.5mm to choose sacculus mould length, by original pipeMaterial is put into sacculus mould, and original tube one end is passed through the high pressure nitrogen of 35atm, other end closing.Original tube is heated to 70 degree, two ends impose the pulling force of 100N, with the draw speed two ends of 120mm/sEach stretching 15mm, shaping is obtained carrying out two ends again after the straight portion of sacculus respectively stretching 5mm and obtains sacculusTapered portion and sacculus pipeline section.Sacculus finally is warming up into 115 degree carries out sizing 30s under 32atm pressure, itLead to recirculated cooling water afterwards to be cooled down, sacculus, the sacculus system of autography performance are taken out from sacculus mouldIt is standby to complete.
After the sacculus heat treatment 30min that will be prepared, laser is carried out to the near-end of sacculus and the distal end of sacculus respectivelyWelding, so that the distal end of the inner tube of sacculus dilating catheter is welded with the sacculus pipeline section of balloon distal, balloon proximalSacculus pipeline section and sacculus dilating catheter outer tube distal end welding, now, after sacculus is folded into three wings,Outer tube is Nian Jie with connector proximally by medical grade glue, so as to prepare the ball with developing functionCapsule dilating catheter.
Embodiment two：5.00mm*15.0mm (length of the flat part of the diameter * sacculus of the flat part of sacculus)The preparation of development sacculus dilating catheter
By blending ratio Pebax70D：BiOCL=60：40 intermingling material extrudes size by extrusion equipmentIt is the original tube of 0.0615inch*0.0350inch (OD*ID), choosing sacculus mould length isThe straight mould of 16.0mm, original tube is put into sacculus mould, and original tube one end is passed through 28atmHigh pressure nitrogen, the other end closing.Original tube is heated to 95 degree, two ends impose the pulling force of 150N,12mm is respectively stretched with the draw speed two ends of 160mm/s, shaping carries out two again after obtaining balloon body partEach stretching 4mm in end obtains sacculus tapering and sacculus pipeline section.Sacculus finally is warming up into 126 degree to be pressed in 30atmSizing 45S is carried out under power, recirculated cooling water is led to afterwards and is cooled down, sacculus is taken out from sacculus mould, it is certainly aobviousThe sacculus of shadow performance is prepared and completed.
Laser welding will be carried out to balloon proximal and balloon distal respectively after the sacculus heat treatment 60min of preparation,So that the distal end of the inner tube of sacculus dilating catheter is welded with the sacculus pipeline section of balloon distal, the sacculus of balloon proximalPipeline section is welded with the distal end of the outer tube of sacculus dilating catheter, now, after sacculus is folded into five wings, by outer tubeIt is Nian Jie with connector proximally by medical grade glue, so as to prepare the balloon expandable with developing functionConduit.
To sum up, it is described in the preparation method of sacculus provided by the present invention, sacculus dilating catheter and sacculusSacculus includes the flat part of the tapered portion at two ends and centre, is designed by the raw material for preparing sacculus,So that the sacculus of manufacture has autography performance, without additionally setting developing mark or using developer, you canObtain the physical location of sacculus, while so that sacculus dilating catheter have it is smaller pass through external diameter with it is more excellentPass through the ability of tortuous lesion so that doctor is more handy in surgical procedure.
Foregoing description is only the description to present pre-ferred embodiments, not to any restriction of the scope of the invention,Any change, modification that the those of ordinary skill in field of the present invention does according to the disclosure above content, belong to powerThe protection domain of sharp claim.