Summary of the invention
The technical problem to be solved in the present invention is that in view of the above-mentioned drawbacks in the prior art, providing a kind of overlay film frame.
The technical solution adopted by the present invention to solve the technical problems is:
A kind of overlay film frame is provided, including hollow tubular body, and is arranged on the side wall of the tubular bodyWindow, the periphery of the window are provided with elastic supporting member for supporting optical member, and development part, the development part packet are provided on the elastic supporting member for supporting optical memberInclude the fixed part being fixedly connected with the elastic supporting member for supporting optical member, the fixed position is in the proximal end region of the elastic supporting member for supporting optical member and remoteExcept end regions.
In overlay film frame of the present invention, the development part includes at least one development section, and the development section is in spiral shellRotation shape is wrapped in the outer surface of the elastic supporting member for supporting optical member, and the development section includes the fixed part, and with the resilient supportThe movable part that part is flexibly connected.
In overlay film frame of the present invention, the fixed position is in the both ends of the development section.
In overlay film frame of the present invention, it is described development section be integrally located at the elastic supporting member for supporting optical member proximal end region andExcept remote area.
In overlay film frame of the present invention, the development section includes that several are wrapped on the elastic supporting member for supporting optical memberSpiral element, the spiral element include two connected interconnecting pieces, the intersection point pair of the interconnecting piece and the elastic supporting member for supporting optical memberAngle between the center line of the tangent line and the interconnecting piece answered is 75 °~90 °.
In overlay film frame of the present invention, the elastic supporting member for supporting optical member is open loop structure, in its natural state, the bulletTwo ends of property supporting element are least partially overlapped.
In overlay film frame of the present invention, the lap of two ends of the elastic supporting member for supporting optical member is located at the bulletThe central region of property supporting element.
In overlay film frame of the present invention, the elastic supporting member for supporting optical member and the development part are coated with wrap member.
In overlay film frame of the present invention, separator is provided between the elastic supporting member for supporting optical member and the development part.
In overlay film frame of the present invention, the development part includes multiple developing cells, the multiple developing cellWhat is be spaced apart from each other is fixed on except the proximal end region and remote area of the elastic supporting member for supporting optical member.
In conclusion implementing a kind of overlay film frame of the invention, with following effective: the application makes the fixation of development partPortion is located at except the proximal end region and remote area of elastic supporting member for supporting optical member, can avoid development part and biggish bending deformation occurs.Also,Since development part and elastic supporting member for supporting optical member are respectively positioned on the periphery of window, the part that develops can be such that the periphery of window has simultaneously with elastic supporting member for supporting optical memberThere are good developability and supportive.
Specific embodiment
In order to make the foregoing objectives, features and advantages of the present invention clearer and more comprehensible, with reference to the accompanying drawing to the present inventionSpecific embodiment be described in detail.Many details are explained in the following description in order to fully understand this hairIt is bright.But the invention can be embodied in many other ways as described herein, those skilled in the art can be notSimilar improvement is done in the case where violating intension of the present invention, therefore the present invention is not limited to the specific embodiments disclosed below.
It should be noted that it can be directly another when element is referred to as " being fixed on " or " being set to " another elementOn one element or there may also be elements placed in the middle.When an element is considered as " connection " another element, it can be withIt is directly to another element or may be simultaneously present centering elements.Term as used herein " vertically ", " level", "left", "right" and similar statement be merely for purposes of illustration, be not meant to be the only embodiment.
Unless otherwise defined, all technical and scientific terms used herein and the skill for belonging to technical field of the inventionThe normally understood meaning of art personnel is identical.It is specific that term as used herein in the specification of the present invention is intended merely to descriptionEmbodiment purpose, it is not intended that in limitation the present invention.Term " and or " used herein includes one or more phasesAny and all combinations of the listed item of pass.
In intervention medical field, usually defining overlay film frame is upon discharge proximal end away from the close one end of heart, remote away from heartOne end be distal end.
Referring to Fig. 1, one of the embodiment of the present application provides a kind of overlay film frame 100, including hollow tubular body 10,And the window 20 on the side wall of tubular body 10 is set, the lumen of tubular body 10 constitutes channel of blood flow.
Tubular body 10 includes bare bracket 101, and the overlay film 102 being connected on bare bracket 101.Bare bracket 101 usesMaterial with good biocompatibility is made, such as NiTi, stainless steel material.Bare bracket 101 includes multi-turn wavy annular object1011, multi-turn wavy annular object 1011 proximally arrives distal end and is successively intervally arranged, or connects into fenestral fabric.Overlay film 102It is made of the high molecular material with good biocompatibility, such as PTFE, FEP, PET.
Fig. 1 and Fig. 2 are please referred to, the periphery of window 20 is provided with elastic supporting member for supporting optical member 30, is provided on elastic supporting member for supporting optical member 30 aobviousShadow part 40, development part 40 includes the fixed part 43 being fixedly connected with elastic supporting member for supporting optical member 30, and fixed part 43 is located at elastic supporting member for supporting optical member 30Proximal end region and remote area except.It should be noted that herein " proximal end region and remote area of elastic supporting member for supporting optical member 30 "Refer to the region that the point on elastic supporting member for supporting optical member 30 away from its vertical range proximally and distally less than or equal to 0.5mm is covered.
Wherein, elastic supporting member for supporting optical member 30 selects the biggish material of elasticity modulus to be made, such as Nitinol, so that window 20Periphery has good compression and rebound characteristics.Part 40 develop using with roentgenopaque characteristic and good bio-compatibleProperty material be made, such as gold, tantalum-niobium alloy, platinumiridio etc. is but this kind of so that the periphery of window 20 has good developabilityThe elasticity modulus of material is smaller, and the elasticity modulus of development part 40 is caused to be less than the elasticity modulus of elastic supporting member for supporting optical member 30.Due to developmentThe elasticity modulus of part 40 is relatively small, is easy to happen plastic deformation.When the part 40 that develops is plastically deformed, it will limit and connect with itThe rebound of the elastic supporting member for supporting optical member 30 connect causes window 20 that can not fully open, and the opening size of window 20 reduces, and then influences to leadThe foundation of wire track.
When overlay film frame 100 is compressed into sheath, meeting radial compression elastic supporting member for supporting optical member 30, elastic supporting member for supporting optical member 30 is close at this timeApparent bending deformation can occur for end and remote area.If development part 40 fixed part 43 be located at elastic supporting member for supporting optical member 30 proximal end orIn remote area, then fixed part 43 can follow elastic supporting member for supporting optical member 30 that apparent bending deformation occurs together, lead to the part 40 that developsDeflection is big, is plastically deformed.The application make to develop part 40 fixed part 43 be located at the proximal end region of elastic supporting member for supporting optical member 30 withExcept remote area, it can avoid development part 40 and biggish bending deformation occur.Also, due to development part 40 and elastic supporting member for supporting optical member 30It is respectively positioned on the periphery of window 20, development part 40 and elastic supporting member for supporting optical member 30 can make the periphery of window 20 have good developability simultaneouslyAnd supportive.
Referring to Fig. 2, development part 40 includes two spaced development sections 44, two development sections 44 are along elastic supporting member for supporting optical member30 proximal end and the line r of distal end are symmetrical arranged, and development section 44 is spirally wrapped around the outer surface of elastic supporting member for supporting optical member 30, and wholeBody is located at except the proximal end region and remote area of elastic supporting member for supporting optical member 30.The cross section of the development silk of composition development section 44 is inscribedCircular diameter is greater than or equal to 0.1mm, preferably 0.1mm~0.5mm, to guarantee that development part 40 has good developability.
Fig. 2 and Fig. 3 are please referred to, development section 44 includes the fixed part 43, and be flexibly connected with elastic supporting member for supporting optical member 30Movable part 42, fixed part 43 are fixed on elastic supporting member for supporting optical member 30 by the modes such as being bonded, welding.Wherein, fixed part 43 is located at aobviousThe both ends of shadow section 44, movable part 42 are located between the both ends of development section 44.That is, the both ends of development section 44 are separately fixed atOn elastic supporting member for supporting optical member 30, the middle section of development section 44 is flexibly connected with elastic supporting member for supporting optical member 30.When deformation occurs, movable part 42It can be relatively moved with elastic supporting member for supporting optical member 30, remove movable part 42 from the big region of the deflection of elastic supporting member for supporting optical member 30, avoid showingShadow section 44 is plastically deformed.Since the both ends of development section 44 are fixed, even if movable part 42 and elastic supporting member for supporting optical member 30 occur relativelyIt is mobile, the whole position on elastic supporting member for supporting optical member 30 of development section 44 is nor affected on, i.e. development section 44 is whole in elastic supporting member for supporting optical member 30On position fix, development positioning preferably can be carried out to window 20.Meanwhile the present embodiment makes development section 44 be integrally located at elasticityExcept the proximal end region and remote area of supporting element 30, the whole deflection for avoiding elastic supporting member for supporting optical member 30 of section 44 that can make to develop is bigRegion further avoids development section 44 and plasticity occurs.
It is understood that the present embodiment does not limit particular number and the position of development section 44, development section 44 can also be wrappedOne or more is included, development section 44 may be alternatively located in the proximal end region and remote area of elastic supporting member for supporting optical member 30, as long as development section 44Fixed part 43 be located at except the proximal end region and remote area of elastic supporting member for supporting optical member 30.For example, embodiment shown in Fig. 4In, development part 40 includes four spaced development sections 44, and development section 44 is spirally wrapped around the outer of elastic supporting member for supporting optical member 30Surface, development section 44 include fixed part 43, and the movable part 42 being flexibly connected with elastic supporting member for supporting optical member 30, and fixed part 43 is located at aobviousThe both ends of shadow section 44, and be located at except the proximal end region and remote area of elastic supporting member for supporting optical member 30, movable part 42 is located at development section 44Both ends between.
It will also be appreciated that the present embodiment does not limit position of the fixed part 43 in development section 44, fixed part 43 is alsoThe other parts that can be located at outside the end of development section 44, as long as being fixed on development section 44 on elastic supporting member for supporting optical member 30.
Referring to Fig. 5, elastic supporting member for supporting optical member 30 is open loop structure, when it is descended in the raw, elastic supporting member for supporting optical member 30Two ends are least partially overlapped.At this point, elastic supporting member for supporting optical member 30 is covered on whole peripheries of window 20, window 20 can be supported completelyShape.Since elastic supporting member for supporting optical member 30 is open loop structure, when flexible deformation occurs, two ends of elastic supporting member for supporting optical member 30 can phaseTo movement, facilitate the radial compression and resilience of elastic supporting member for supporting optical member 30.In order to avoid two ends of elastic supporting member for supporting optical member 30 existIt is stretched out from the gap between screw of development section 44 when relatively moving, the internal diameter for the helical structure that development section 44 surrounds is greater than elasticityThe outer warp of supporting element 30, so that the end of elastic supporting member for supporting optical member 30 is always positioned at aobvious when flexible deformation occurs for elastic supporting member for supporting optical member 30In the helical structure that shadow section 44 surrounds.
Since the deflection in the proximally and distally region of elastic supporting member for supporting optical member 30 is big, if two ends of elastic supporting member for supporting optical member 30Lap is located on or near the proximally and distally region of elastic supporting member for supporting optical member 30, when deformation occurs, the end of elastic supporting member for supporting optical member 30Portion is easy to stretch out from the gap between screw of development section 44, influences the subsequent relative movement of the two.Therefore in order to avoid two endBetween the influence that deforms by bending of relative movement, the lap of two ends of elastic supporting member for supporting optical member 30 is located at elastic supporting member for supporting optical member30 central region.It should be noted that " central region of elastic supporting member for supporting optical member " refers on elastic supporting member for supporting optical member 30 away from it hereinThe region that point of the vertical range proximally and distally more than or equal to 2mm is covered.
Elastic supporting member for supporting optical member 30 is in ellipticity, and for long axis m substantially along the axis direction for being parallel to overlay film frame 100, short axle n is bigIt causes along the axis direction perpendicular to overlay film frame 100.Since the size of short axle n is relatively small, when overlay film frame 100 is compressed into sheathGuan Shi, elastic supporting member for supporting optical member 30 are easier to be radially compressed, and the screen resilience generated in sheath is smaller, when being also beneficial to reduce releaseResistance.In the present embodiment, the ratio of the long axis m and short axle n of elastic supporting member for supporting optical member 30 meet 3/2≤m/n≤3, in favor of elasticityThe radial compression and resilience of supporting element 30.
Fig. 6 a and Fig. 6 b is please referred to, development section 44 includes that several are wrapped in the spiral element 41 on elastic supporting member for supporting optical member 30,Spiral element 41 includes two connected interconnecting pieces 410, respectively first connecting portion 410a and second connecting portion 410b.Wherein,Angle between interconnecting piece 410 tangent line b corresponding with the intersection point of elastic supporting member for supporting optical member 30 and the center line a of interconnecting piece 410 is α, 75 °≤α≤90°.Fig. 7 a and Fig. 7 b is please referred to, if the tangent line b corresponding with the intersection point of elastic supporting member for supporting optical member 30 of interconnecting piece 410 and interconnecting pieceAngle α between 410 center line a is smaller, and when 30 bending deformation of elastic supporting member for supporting optical member, development section 44 can follow elastic supporting member for supporting optical member30 bending deformations together, to influence the relative movement developed between section 44 and elastic supporting member for supporting optical member 30.Also, due to section 44 of developingElasticity modulus it is relatively small, when deformation occurs, development section 44 be easy to appear plastic deformation, influence elastic supporting member for supporting optical member 30 timeBullet.Therefore above-mentioned angle α is arranged within the scope of 75 °~90 ° the application, can make to develop between section 44 and elastic supporting member for supporting optical member 30The influence that does not deform by bending of relative movement, while development section 44 being avoided to be plastically deformed.
It is understood that the application does not limit the specific structure of elastic supporting member for supporting optical member 30, as long as guaranteeing elastic supporting member for supporting optical member30 are flexibly connected with development section 44, and in other embodiments, elastic supporting member for supporting optical member 30 can also be closed loop configuration or annular shapeStructure etc..For example, in the embodiment shown in fig. 8, elastic supporting member for supporting optical member 30 is elliptoid closed loop configuration.Alternatively, in Fig. 9 a andIn embodiment shown in Fig. 9 b, elastic supporting member for supporting optical member 30 is elliptoid open loop structure, in its natural state, elastic supporting member for supporting optical member 30Two ends are least partially overlapped, and development section 44 is spirally wrapped around the outer surface of elastic supporting member for supporting optical member 30.Elastic supporting member for supporting optical member 30Two ends be provided with spherical portion 31 or cyclic structure 32, the radial dimension of the spherical portion 31 and cyclic structure 32 is greater than adjacentGap between two first connecting portion 410a (or second connecting portion 410b), to avoid development section 44 and 30 phase of elastic supporting member for supporting optical memberThe end of elastic supporting member for supporting optical member 30 is pierced by from the gap between screw of development part 40 when to movement, it is ensured that two ends of elastic supporting member for supporting optical member 30Portion is always positioned in the helical structure that development part 30 surrounds.
Since elastic supporting member for supporting optical member 30 and development part 40 are made of metal material, there is potential difference therebetween, if directlyIt connects and contacting blood, is easy to produce electrochemical corrosion and chemical attack, cause elastic supporting member for supporting optical member 30 and development part 40 to be broken, fractureElastic supporting member for supporting optical member 30 or development part 40 can cause serious injury to patient into body-internal-circulation.Therefore when assembly, it can will be connected withThe elastic supporting member for supporting optical member 30 of development part 40 is put into hollow wrap member (not shown), then wrap member is fixed on to the week of window 20Side.
Wrap member is cyclic structure, and the high molecular material with good biocompatibility is used to be made, preferably impermeablePTFE, ePTFE etc. of blood.Elastic supporting member for supporting optical member 30 is mobilizable to be placed in wrap member, and wrap member does not influence elastic supporting member for supporting optical member 30Being flexibly connected between development part 40.Since wrap member is coated on outside elastic supporting member for supporting optical member 30 and development part 40, even if elasticity branchSupport member 30 or development part 40 are broken, and fault structure will not enter human body and damage to patient.
When actual fabrication, after window 20 is opened up on overlay film 102, the elastic supporting member for supporting optical member 30 for being connected with development part 40 is placedOn the periphery of window 20, then the overlay film 102 on 20 periphery of window towards the fold of the side of elastic supporting member for supporting optical member 30 and is propped up elasticitySupport member 30 is wrapped up wherein, is finally fixedly connected with the overlay film 102 inside and outside elastic supporting member for supporting optical member 30.That is, this implementationThe wrap member of example is formed by the fold of overlay film 102 on 20 periphery of window.It is understood that the present embodiment does not limit wrap memberSpecific structure as long as can be coated on outside elastic supporting member for supporting optical member 30 and development part 40, and does not influence the flexible connection of the two.ExampleSuch as, in other embodiments, wrap member and overlay film 102 are individual components, and wrap member is fixed on window 20 by way of suturePeriphery.
Further, due to development part 40 it is a part of it is mobilizable be wrapped on elastic supporting member for supporting optical member 30, when the two occurWhen relative movement, the frictional force between part 40 and elastic supporting member for supporting optical member 30 of developing is easy to cause elastic supporting member for supporting optical member 30 or development part 40 disconnectedIt splits.Therefore separator (not shown) is provided between the elastic supporting member for supporting optical member 30 of the application and development part 40, separator is used with goodThe material of good biocompatibility is made, such as PTFE, FEP, PET.By separator by elastic supporting member for supporting optical member 30 and development part 40 everyFrom not only both avoidable directly contact generates friction, the generation of also avoidable electrochemical corrosion and chemical attack.
Referring to Fig. 10, the two of the application preferred embodiment provide a kind of overlay film frame, no with one of embodimentIt is with place, development part 40 includes multiple developing cells 45, and what multiple developing cells 45 were spaced is fixed on elastic supporting member for supporting optical member 30Proximal end region and remote area except.Multiple fixing grooves are provided on elastic supporting member for supporting optical member 30, developing cell 45 is fixed on correspondenceFixing groove in.
Each technical characteristic of embodiment described above can be combined arbitrarily, for simplicity of description, not to above-mentioned realityIt applies all possible combination of each technical characteristic in example to be all described, as long as however, the combination of these technical characteristics is not depositedIn contradiction, all should be considered as described in this specification.
The embodiments described above only express several embodiments of the present invention, and the description thereof is more specific and detailed, but simultaneouslyIt cannot therefore be construed as limiting the scope of the patent.It should be pointed out that coming for those of ordinary skill in the artIt says, without departing from the inventive concept of the premise, various modifications and improvements can be made, these belong to protection of the inventionRange.Therefore, the scope of protection of the patent of the invention shall be subject to the appended claims.