A kind of valvular transportation system of intervention convenient for manipulationTechnical field
The present invention relates to medical instruments fields, more particularly it relates to which a kind of be implanted to the heart for heart valve prosthesisDirty transportation system.
Background technique
Heart valve disease is one of most common heart disease in China, wherein predominantly valve lesions caused by rheumatic fever；Recently as the development of aging of population, valve retrogression (including calcification and mucinous degeneration etc.) and dysbolism valveMembrane damage is also increasing in China；In addition, congenital valve disease is also one of cardiopathic common disease factor.Considerable heartFor example serious valvular inadequacy of the high risk cases of valvular heart disease, advanced age are unsuitable for surgery heart valve replacement surgery, late tumor and valve is closedInfull patient etc. needs the interventional method treatment that new wound is small.Intervening heart valve is in surgery cardiac valve replacement handDevelop under the inspiration of art, in recent years, percutaneous valve interventional procedure comes into being and sequential use takes with the mankind after 2000Obtained success.Small-scale clinical parallel conceptual phase is developed to from experimental study, valvular heart disease is intervened on possible break-through skill" bottleneck " realizes rapidly extensive clinical application, becomes the focus in Interventional Cardiology field again.
In the prior art, it is conveyed into the human body after prosthetic heart valve holder compression by conveying device, the valve of compressionBracket usually has elasticity, when in a compressed state to apply very big power to compression tube, these excessive power are difficult to make valveBracket slowly accurately discharges, and often leads to the excessive friction of valve bracket and blood vessel.
The Chinese patent literature of Publication No. CN101953725 discloses a kind of prosthetic heart valve holder, by aortaBracket, valve bracket, efferent tract bracket and engaging lug composition, when heart valve is compressed in conveying device, the engaging lug energyIt is enough engaged in the bracket fixation kit of conveying device, passes through the engaging and outer sheath of engaging lug during valve bracket releaseCollect complete valve bracket slow release.However, engaging smaller, the In that collects power of valve bracket engaging lug in the prior artValve bracket discharges the process later period, and engaging lug is easily popped up from conveyor support fixation kit, releases that valve bracket completelyIt puts.At this point, if the problems such as finding deviations, just can not be recycled in time, can only pass through surgical replacement.
To overcome the valve bracket existing above problem, United States Patent (USP) US5683451 during being implanted into human body release publicThe delivery apparatus and method of a kind of valve bracket control release are opened, the method by the way that track is arranged in conveying device is reducedConvey and discharge valve prosthesis when elastic dilatation frictional force caused by delivery conduit, foregoing invention reduce valve bracket withFriction between delivery conduit.However, the problem of valve bracket discharges due to elastic force is excessive completely suddenly during release is stillCan not solve, the valve bracket after release is in place cannot achieve the adjustment or secondary in place of position, so not only to operation whenControl accuracy requirement is high, and there is also certain risks.
Handle is located at the proximal end of transportation system, it is located at outside human body at the time of surgery, is operated by doctor；Intervene heartValve is loaded in the loading section positioned at transportation system distal end after usually being compressed, percutaneous puncture enters in human body, when being delivered to diseaseWhen displacement is set, by the control of handle, the outer sheath being wrapped in outside intervention heart valve, interposers release expansion are withdrawn.Due toIntervention heart valve is tightly compressed the loading section in outer sheath, thus its there are biggish frictional force between outer sheath, beThis needs the control by handle when release intervenes heart valve at the beginning, and slow release intervenes heart valve, leads to again laterHandle control is crossed, quick release intervenes heart valve.
The needs when handle of transportation system is performed the operation according to intervention at present, generally use second order rate control, for controllingIt intervenes valvular release and withdraws, comprising: quickly control, for Quick-return or release intervention heart valve；It controls at a slow speedSystem, for slow release or withdraws intervention heart valve.
Control section drives by rotating the screw knob positioned at handle proximate end tail portion and withdraws epitheca existing handle at a slow speedPipe, threads turn stroke is short, in addition human vas is full of twists and turns, is difficult the torsion of rotation being transmitted to the remote of transportation systemEnd, when this leads to operation, doctor needs bigger power to remove rotation knob, to withdraw outer sheath.
It is currently used for conveying and intervenes the outer outer sheath of valvular conveying mostly by high molecular material manufacture at although macromoleculeThe attribute performance of material is good, but its elasticity and intensity are poor.Although being applied to macromolecule using by reinforcement material currently, also havingIn material, such as woven network tube or elastic tube do and reinforce, by high molecular material coating outside the inside and outside formation of reinforced pipe epithecaPipe, still, above-mentioned measure only increases the fold resistance and pressure-bearing property of outer outer sheath, and obviously solves epitheca and withdraw JieThe problem of intervention heart valve encountered when entering heart valve is difficult to recycle, outer sheath fold.
Summary of the invention
The present invention provides a kind of valvular transportation systems of the intervention convenient for manipulation, can release in intervention heart valveFirmly fastening valve bracket finally discharges end during putting, and intervenes heart valve by operation handle stability contorting, is being situated betweenIt is not only stable to have operation easy to be easily steady but also easy during entering heart valve installation or discharging or when valve releasing position is undesirableResetting intervene heart valve.
A kind of valvular transportation system of intervention convenient for manipulation, including core-pipe subassembly, is in core-pipe subassembly peripheryAlong the handle of the axially opposing sliding of outer sheath, the handle includes tubulose for outer sheath and control core-pipe subassembly and outer sheathOntology, have in the ontology axially through inner cavity, the proximal end of the core-pipe subassembly and outer sheath, which is worn, is mounted on handIn the ontology of handle, along the first control mechanism for being axially arranged with adjusting outer sheath and core-pipe subassembly axial position respectively of the handleWith the second control mechanism, first control mechanism is located at the axial middle part of ontology and drives epitheca by way of being threadedly engagedPipe axial movement, second control mechanism are located at the proximal lateral of ontology and drive core-pipe subassembly phase by mode in axial slidingOuter sheath is moved axially；
The core-pipe subassembly is fixed with seeker and fixing head, and wherein seeker is fixed on core-pipe subassembly distal end, core pipe groupFixing head is extended in part proximal lateral, is intervention heart valve installation position between seeker and fixing head；It is additionally provided with floating position-limiting item,The proximal end of the floating position-limiting item is the starting point being fixedly installed relative to fixing head or core-pipe subassembly, and the floating of floating position-limiting item is being situated betweenEnter between heart valve installation position and outer sheath；
The outer wall of the fixing head is equipped with the positioning region for matching with the valvular engaging lug of intervention, the connectionBefore ear is completely released out outer sheath, the floating position-limiting item is fettered by outer sheath and is kept for matching between engaging lug and positioning regionIt closes；
The outer sheath includes successively from inside to outside internal layer, middle layer and outer layer, and the middle layer is by distal end to proximal endIt successively include first segment, second segment and third section, the first segment is engraved structure, and the engraved structure includes at least twoHollow-out unit, distal end disconnected from each other setting of the two adjacent hollow-out units in the first segment circumferential direction.
In the present invention, when being proximally precisely controlled the release of distal end valve by screw type operation handle, and needingValve is withdrawn, and is easily facilitated medical worker and is held and operate, and floating position-limiting item is located between outer sheath and intervention heart valve, hasEffect filling outer sheath and intervention heart valve engaging lug gap in the radial direction, reinforce, reinforcement outer sheath is radially to connectionThe binding force of ear is reinforced stabilization, fastness that intervention heart valve engaging lug is connect with fixing head, is prevented in intervention heart valveEngaging lug is detached from fixing head and is unable to control before discharging completely, and in the case where valve release is undesirable, can for intervention valveAgain it is retracted secondary positioning in outer sheath or strong, the stable pulling force of offer is provided；Meanwhile outer sheath is by interior centreLayer, not only enhance outer sheath axial support force, while can radial expansion drop promote valve radial contraction, reduction withdraw duringResistance.That is, on the one hand and by controlling handle medical worker is allowed proximally to carry out ease of Use, guaranteeing to the steady of valveIt in the case where determining back pull, reduces valve and has discharged the partially recycled resistance in outer sheath, complete to release intervention heart valvePut or the manipulation of removal process precisely, safe release or secondary adjustment release, effective and safe realization intervention heart valve conveyRelease and repeatable positioning.
Floating position-limiting item can for intervention heart valve or core-pipe subassembly in the case where no outer sheath is fetteredRelative position and posture are kept with the strength of materials for freely swinging or relying solely on itself.
After intervention heart valve is loaded into outer sheath, or before being completely released out outer sheath, the floating position-limiting itemThe cooperation kept between engaging lug and positioning region is fettered by outer sheath；Outer sheath is withdrawn, and during gradually discharging engaging lug, is floatedDynamic positive stop strip is also gradually released outer sheath, and when engaging lug discharges completely and is detached from fixing head, floating position-limiting item can be certainlyBy swinging, the floating position-limiting item being released no longer applies radial pressing force to engaging lug, that is, determines that intervention heart valve is in placeAfter good, outer sheath will continue to withdraw, and by release engaging lug and floating position-limiting item, release the floating position-limiting item of outer sheath at this timeTo engaging lug, infinite place is acted on, secondary interference will not be caused to cause to intervene valvular displacement to intervention heart valve.
After intervention heart valve is loaded into outer sheath, floating position-limiting item also plays the effect of gasket, can compensate outerFit tolerance between sheath and intervention heart valve engaging lug, filling outer sheath and intervention heart valve engaging lug are radiallyGap, floating position-limiting structure is simple, to gap fill up not will increase valve implantation when transportation system radial dimension；It is the reinforcing enhancing to cooperation is connected between existing intervention valve and fixing head, switching performance is more stable；Floating position-limiting item is to evenThe radial pressure of lug synchronizes disappearance with withdrawing for outer sheath, will not cause new interference to good valve has been discharged.
Preferably, the starting point of the floating position-limiting item and at least one of the fixing head or the core-pipe subassemblyIt is mutually fixed.
The fixation of floating position-limiting starting point is located proximate to fixing head, such as is in fixing head proximal end and (leans on along transportation systemProximal operator direction) tail portion or the core-pipe subassembly that is connected with the tail portion on, before surgery by outer sheath to intervention heart valveFilm and floating position-limiting item are collected, so that radially containing note leans against intervention heart valve periphery to floating position-limiting item, are being intervenedHeart valve reach in vivo after release during, floating position-limiting item with the recession of outer sheath and the release of valve bracket and diameter is outsideIt sticks up.
In order to control the valvular axial position of intervention, match intervening valvular proximal end and being typically provided with fixing headThe engaging lug of conjunction, engaging lug generally can be used using T shape, L shape, annular etc., positioning region and be received T shape, L-shaped positioningSlot, or be caught in the plush copper etc. of annular makes to intervene the laden axial position of heart valve and is limited to positioning region, in the present invention evenThe prior art can be used for lug shape itself, and the improved emphasis of non-present invention.
Preferably, the positioning region is positioning plush copper, after the intervention heart valve loads, the engaging lug is set inIt positions in plush copper, before the engaging lug is completely released out outer sheath, the floating position-limiting item is laminated on engaging lug to keepCooperation between engaging lug and positioning region.
Preferably, the positioning region is locating slot, after the intervention heart valve loads, engaging lug is inlaid in accordinglyIn locating slot, before the engaging lug is completely released out outer sheath, the floating position-limiting item is laminated on engaging lug with the company of holdingCooperation between lug and positioning region.
When for example, by using locating slot, engaging lug is caught in locating slot after intervention heart valve loads, to realize axially position,After outer sheath is withdrawn, radially outward abjection locating slot of the engaging lug along bracket.
It can be combined with plush copper structure when using locating slot, i.e., plush copper be set in the slot bottom of locating slot, mating connection earLocating effect can be enhanced in respective shapes.
Preferably, the floating position-limiting item is identical as positioning slot number, and circumferential position corresponds.
Locating slot can guarantee that floating position-limiting item will not deviate during collecting with release.
The proximal end position of floating position-limiting item is linked closely under outer sheath package after valve loads locating slot and embeds company thereinLug.During outer sheath drops back release valve bracket, by floating position-limiting item in the extruding fastening effect of locating slot, preventIt the quick release of valve bracket and falls off.In valve bracket release process discovery deviations, it can be pushed forward outer sheath, toThe valve bracket of release is compressed and is recycled, and engaging lug is tightly wrapped up by floating position-limiting item and outer sheath at this time, is effectively ensuredThe security control of valve bracket and secondary positioning.
Preferably, the end of the floating position-limiting item at least extends to position corresponding with the engaging lug.I.e. at leastCovering part engaging lug, to realize constraint to engaging lug radial motion, the end of floating position-limiting item can be on this basisFurther extend towards distal end.
The end of the floating position-limiting item is for starting point, and end also is understood as the distal end of floating position-limiting itemSide.
Preferably, the distalmost end of the floating position-limiting item is aligned with fixing head distalmost end or is no more than fixing head distalmost endOr only slight beyond fixing head distalmost end.
When the floating position-limiting item has minimum length, floating position-limiting item can at least cover the engaging lug.In order intoOne step guarantees compression effect, and the end of floating position-limiting item may be further extended to the distal side of fixing head or only slight beyond fixing headDistal side, such as more than length be less than or equal to 1cm.When floating position-limiting item has maximum length, floating position-limiting item is integrally equalIt can guarantee and be convergent in outer sheath, and floating position-limiting end is flushed with the valve bracket distal side inside outer sheath, is floated at this timeThe length of dynamic positive stop strip can wrap up entire valve bracket, and floating position-limiting item plays the role of sliding rail, guarantee that outer sheath being capable of edgeSliding rail is pushed forward and withdraws and is not directly contacted with valve bracket.
After intervening heart valve loading, the floating position-limiting item is fettered by outer sheath and engaging lug is limited in locating slot,Epitheca inside pipe wall contacts with floating position-limiting item and provides radial constraint, and engaging lug can be blocked in locating slot by floating position-limiting itemIt is interior, it prevents from.
Preferably, the locating slot is axially through at the position of, the floating position-limiting item and locating slot cooperation, part orAll sink in locating slot.
The floating position-limiting item extends via locating slot to distal end, and locating slot is not only axially through radial outside is alsoOpen, that is, there is radial opening, strictly limitation is not completely disposed on the inside of radial opening floating position-limiting item, is admitted of at partIn the outside of radial opening, such as floating position-limiting section is T shape, and locating slot is protruded into for stopping engaging lug in T shape bottom end, and TShape top dimension is limited to radial opening, therefore is in the outside of radial opening, can only guarantee and epitheca inside pipe wall in this wayCooperation, can also take into account the cooperation with engaging lug.
Preferably, the locating slot is closed axially through region by floating position-limiting item.
Engaging lug is deviate from order to prevent, the width of floating position-limiting item can it is identical as the radial opening axially through region orSlightly wide, realization completely encloses radial opening, even if width is less than the width of radial opening, gap is at least unlikely to connectThe abjection of ear, the width of floating position-limiting item is preferably identical as the radial opening axially through region, and can further prevent floating limitsPosition item offset.
Preferably, the floating position-limiting item sinks to the part of locating slot, engaging lug is inwardly contacted or pushed against radially.
Floating position-limiting item is although can stop engaging lug, the thickness (radial dimension) of the two and the depth of locating slotThere can be different matching relationships, in the case where outer sheath coats contact fixing head periphery, floating position-limiting item is stacked in connectionThe outer wall of ear, if the thickness of floating position-limiting item and engaging lug and the depth greater than locating slot, floating position-limiting item are inside radiallyPush against engaging lug, on the contrary it is then contact, apparent binding force can't be generated, but can guarantee floating position-limiting item with to companyThe limit of lug, as a further preference, using the relationship of abutting, it is ensured that when axial force is excessive or outer sheath local deformationIt still keeps limiting.
Preferably, the floating position-limiting item is radially with the outer wall of fixing head etc. after intervention heart valve loadsOuter wall high or higher than fixing head.
Floating position-limiting item is not less than the outer wall of fixing head radially, can to avoid floating position-limiting item and epitheca inside pipe wall itBetween generate unnecessary gap so that epitheca inside pipe wall is close to floating position-limiting item, and engaging lug is pressed on to the positioning of fixing headIn portion.
Optionally, extend at the position of the floating position-limiting item and engaging lug cooperation along straight line or curve.
When floating position-limiting two sides and locating slot corresponding side offset, floating position-limiting width can be appropriate when extending along curveNarrow, intervene heart valve release when be easier to bending it is turned-out stick up avoided with discharging engaging lug engaging lug deviate from sluggishness.
Optionally, wide or not wide extension at the position of the floating position-limiting item and engaging lug cooperation.
Optionally, uniform thickness or uniform thickness extension at the position of the floating position-limiting item and engaging lug cooperation.The floating limitThe position of position item and engaging lug cooperation either extends along straight line or curve, can be set as not wide and/or not uniform thickness, lead toThe variation adjusting local strength for crossing width, thickness, takes into account limit and release engaging lug.
Preferably, the end of the floating position-limiting item has smooth outer peripheral surface.
The radial development with the release of valve bracket of floating position-limiting item described in use process, to prevent the end after expansionBlood vessel is stabbed, therefore end uses smooth outer profile, such as similar to the forms such as spherical crown or edge rounded corner.
Preferably, the floating position-limiting item is circumferentially uniformly arranged 2,3 or 4.
Preferably, each floating position-limiting equal or different length.
When Length discrepancy, each floating position-limiting terminal position can be different, such as wherein at least a floating position-limiting end is prolongedExtend to the distal side flush with fixing head；An at least floating position-limiting end extends to the distal end of intervention heart valve installation positionSide.
It preferably, the floating position-limiting item is isometric 3, and is strip structure.
Preferably, the floating position-limiting item is hollow or solid construction.
Preferably, the floating position-limiting item is solid flat strip shaped.
Radial direction using flat strip shaped structure in intervention heart valve installation position occupies little space, and is conducive to reduce compressed outerDiameter.
Preferably, the size of the floating position-limiting item are as follows: length 10mm-80mm, width 1-2mm, thickness 0.2-0.5mm。
Preferably, the floating position-limiting item is fixed on institute using bonding, binding, lock, welding or integrated modeOn the component of connection.
Described floating position-limiting one end is starting point, and the other end is end, and intermediate position is extended segment, the starting point positionConnecting portion in the tail portion of fixing head proximal end or tail portion and interior sheath, in a manner of bonding, binding, lock, welding or integrationIt is fixed on connected component.Floating position-limiting item extends along starting point to distal end, in its natural state, the floating position-limiting itemStarting point is fixed, and extended segment and end axially unfold opening along core-pipe subassembly.
Optionally, when intervening heart valve loading condition, the floating position-limiting distal head is axially at least partly laminated onOn the engaging lug.
Optionally, engaging lug and fixing head are laminated in the floating position-limiting distal head axial direction.
Optionally, engaging lug and entire fixing head are laminated in the floating position-limiting distal head axial direction.
Optionally, the floating position-limiting distal head is more than fixing head distal end to intervening valvular diameter maximum portionPosition.
Preferably, the floating position-limiting item and outer sheath cooperation position, and in the position of support assorted, at leastHave at one with smooth surface and/or with lubricant coating.
Preferably, the floating position-limiting item is polytetrafluoroethylene material.
Preferably, being additionally provided with positioned at epitheca inside pipe wall and the fixed guide item that axially extends.
Fixed guide item is fixed on outer sheath distal tubular enclosure interior, axis of the fixed guide item along tubular shell on one sideTo being disposed to extend.Outer sheath collect with discharge valve bracket during, valve bracket with positioned at outer sheath tubular shell it is intracorporalFixed guide item directly contacts, and quick, the control accurate of valve bracket are carried out by the smooth track that fixed guide item provides.
It can be contact portion between fixed guide item and epitheca inside pipe wall or be all fixedly linked, or use and be spaced apartMultiple fixed points, since fixed guide item needs to move back and forth with outer sheath, preferably, the axial direction of fixed guide itemBoth ends are at least fixed with epitheca inside pipe wall, to avoid the space interference for turning over and sticking up when causing movement is generated.
Operation consent outer sheath collects valve bracket, and fixed guide item is close to valve bracket.It is released in subsequent valve bracketIn putting, fixed guide item provides smooth rail (close to the one side of valve bracket) between outer sheath tubular shell and valve bracketRoad reduces contact friction, convenient for the release and control of valve bracket.
" floating " gib block and " fixation " gib block are that in contrast, " floating " refers to that one end is fixed, and another in the present inventionOne end can at least be swung radially in the case where no external constraint, and due to the limitation of own material intensity, generallyAlso allow that circumferential offset occurs.
Preferably, the floating position-limiting item is alternately arranged with fixed guide item along week.
Locating slot in the distribution and fixing head of each fixed guide item is staggered, and also implies that and floating position-limiting item and solidDetermine gib block to be staggered.
Preferably, the end of the floating position-limiting item is identical as the axial position of the distal side of fixed guide item or interlocksArrangement.
Preferably, the fixed guide item is circumferentially uniformly arranged 2,3 or 4.
Preferably, each fixed guide equal or different length.
It preferably, the fixed guide item is isometric 3, and is strip structure.
Preferably, the fixed guide item is hollow or solid construction.
Preferably, the fixed guide item is solid flat strip shaped.
Radial direction using flat strip shaped structure in intervention heart valve installation position occupies little space, and is conducive to reduce compressed outerDiameter.
Preferably, the size of the fixed guide item are as follows: length 10mm-80mm, width 1-2mm, thickness 0.2-0.5mm。
Preferably, the length 60mm-80mm of the fixed guide item.
In the present invention, the floating position-limiting item, the shape of fixed guide item and size are arranged independently of each other, such as can be withIt is the solid or hollow structure of strip；Its cross sectional shape is preferably flat, in order to reduce the whole radial dimension in outer sheath distal end,Thickness direction, that is, outer sheath radial direction of flat pattern.
For the ease of controlling the release and recycling of bracket, the contact area with outer sheath is reduced, to reduce between the twoRelative friction, floating position-limiting item, fixed guide item also have the selection of suitable size accordingly.
Preferably, the fixed guide item is using bonding, binding, lock, welding or the fixed epitheca of integrated modeInside pipe wall.
Preferably, the position of the fixed guide item and intervention heart valve cooperation has smooth surface and/or hasLubricant coating.
Preferably, the fixed guide item is polytetrafluoroethylene material.
In the present invention, the floating position-limiting item, fixed guide item material mutually independent can choose, as preferably adoptingIt is made of elastic preferable biocompatible materials, the selection of specific material can use the prior art.
To guarantee that floating position-limiting item, fixed guide item have suitable elastic and the smallest dynamic friction factor, it is preferable that slidingPolytetrafluoroethylene (PTFE) (PTFE) can be selected in rail material.After valve bracket discharges in human body, sliding rail is dropped back with transportation system, after sliding railFriction is contacted with the valve bracket discharged completely during removing, for the bullet during the recession of anti-anti-slip track between valve bracketPower will not move bracket, it is furthermore preferred that the outer surface of floating position-limiting item or fixed guide item is as smooth as possible or is arranged on surfaceHydrophilic monomer or high molecular polymer with lubrication property, such as N, N- diformazan can be selected in lubricant coating, lubricating coating materialsBase acryloyl (DMAA), acrylamide (AAm), n-vinyl pyrrolidone (NVP), polyvinyl alcohol (PVA), polyacrylamide(PAAm), above-mentioned coating material is attached to floating position-limiting item by coupling agent or chemical method or consolidated by polyethylene glycol (PEG) etc.Determine the outer surface of gib block.
In the outer sheath, the internal layer, the middle layer and the outer layer along the outer sheath radial direction successivelyBe arranged from the inside to the outside, the first segment, the second segment and the third section to the outer sheath distal end to described outerThe proximal end of sheath is sequentially distributed.
Circumferential direction due to the hollow-out unit on the first segment in the distal end of the first segment is disconnected from each other.First segment can be suitableIt answers the internal layer and outer layer and expands, to have foot while making the distal end of the outer sheath with better scalabilityEnough axially and radially support forces, and hollow-out unit is in rounding state, to further provide for enough axial directions and diameterTo support force.So that enough axially and radially support forces are provided, so as to be given an account of in intervention heart valve removal processEnter heart valve fast, safely to recycle.
Two adjacent hollow-out units are set between the distal end of the first segment circumferential direction in one of the embodiments,There is hollow out gap, the range of the hollow out gap L is between 0.5mm-8mm.
Axial not closed space is formed between two adjacent hollow-out units in one of the embodiments,.
The hollow-out unit in the first segment circumferential direction forms multiple hollow-out unit groups, phase in one of the embodiments,It is circumferentially disconnected from each other in the first segment between two groups of adjacent hollow-out unit groups.
Two adjacent hollow-out units are mutual between the distal end of the first segment circumferential direction in one of the embodiments,It mutually separates, is interconnected in the proximal end of the first segment circumferential direction or independent mutually, and connect with the second segment.
At least one hollow hole is offered in the hollow-out unit in one of the embodiments, the hollow hole is along instituteIt is axial from distally proximally extending to state hollow-out unit.
The hollow-out unit includes at least one hollow out segment in one of the embodiments, is opened on the hollow out segmentEquipped with hollow hole described at least one.
The hollow out hole area accounts for the 40-80% of the hollow-out unit area in one of the embodiments,.
The hollow out hole area accounts for the 60-70% of the hollow-out unit area in one of the embodiments,.
The distal end of the hollow-out unit is equipped with arc section, the arcuate directions of the arc section in one of the embodiments,Protrude setting in the distal end of the hollow-out unit.
The radius of the arc section is 0.3mm-16mm in one of the embodiments,.
It is the delivery conduit, described the present invention also provides a kind of epitheca, including delivery conduit, coupling tube and outer sheathCoupling tube and the outer sheath are sequentially connected from the outer sheath distal to proximal end, the axis of the delivery conduit, the transitionPipe axis and the outer sheath axis are overlapped setting.
The present invention also provides a kind of intervention heart valve conveying devices, for conveying intervention heart valve, including core pipe groupPart, epitheca, control handle, the core-pipe subassembly are connect with the control handle, and the epitheca is slidably set in the core pipeOn component, the intervention heart valve is loaded on the core-pipe subassembly, and is housed in the outer sheath of the epitheca.
The first control machine is respectively set in the adjusting that relative motion between outer sheath and core-pipe subassembly is realized in the present inventionStructure and the second control mechanism, the axial middle part that the first control mechanism is located substantially at ontology is more easier the control of grip, and usesThe mode being threadedly engaged drives outer sheath, and in conjunction with the characteristics of screw thread, implementable low-speed fine is adjusted.Second control mechanism is located at thisThe proximal lateral of body does not have space interference with other component when recession, quickly adjusts core-pipe subassembly in an axially slidable way.
Preferably, the periphery wall of the ontology is equipped with axially disposed gib block hole, first control mechanismInclude:
The distal side of the push rod being located within the body, the push rod connects the outer sheath；
It is mounted on push rod and extends radially the STATEMENT OF FEDERALLY SPONSORED in gib block hole；
It is sleeved on the rotating handle of body exterior, the inner wall of the rotating handle is equipped with the interior spiral shell matched with the STATEMENT OF FEDERALLY SPONSOREDLine.
The ontology of tubulose has inner cavity, in order to realize the linkage of external rotating handle and internal push rod, opens up on the bodyGib block hole, provides the evacuation channel that STATEMENT OF FEDERALLY SPONSORED is axially moved, and the inner wall of rotating handle, using being threadedly engaged, is turning with STATEMENT OF FEDERALLY SPONSOREDDrive STATEMENT OF FEDERALLY SPONSORED that push rod is driven to be axially moved by screw thread commutation when dynamic rotating handle, push rod drives outer sheath to realize opposite core pipeThe slow tune of component.
Preferably, being equipped with mutually matched axial limiting component between the rotating handle and ontology.
Rotating handle need to keep axial position, it is only necessary to rotate around body axis, the axial limiting component of use can be itThe mutually matched collar structure between ontology, such as one of them have annular convex platform, and another one is with the receiving convex annularThe annular groove of platform cooperates and implements axially position.
Preferably, being integrally formed or being fixedly connected between the STATEMENT OF FEDERALLY SPONSORED and push rod.Such as in processing, pass through injection moldingIt is integrally formed, or is achieved a fixed connection by the modes such as being first socketed or pasting.
It is fixedly connected, direct axial can be driven between STATEMENT OF FEDERALLY SPONSORED and push rod, according to being threadedly engaged, then can be pre-adjustedThe relative position of STATEMENT OF FEDERALLY SPONSORED and push rod can compensate installation or mismachining tolerance to a certain extent, can be with according to being threadedly engagedIt is the local setting screw thread in cooperation, and screw pitch is relatively small, convenient for accurate positioning, preferably also sets up locking piece, such asLocking nut or pin etc., by STATEMENT OF FEDERALLY SPONSORED and push rod mutually locking.
Preferably, at least one is seperated fastening structure, and seperated part is at least in the ontology and rotating handleTwo valves are in the side of body axis respectively, are equipped with mutually matched grafting positioning element between adjacent petals.
Seperated fastening structure easily facilitates assembly and disassembly, can avoid the space interference for turning timing, such as ontology and rotationIt is all respective by the way of two valves fastening to change hands handle, by taking rotating handle as an example, two valves substantially arc tiles, after mutually fasteningAs tubular, the structures such as elastic block tongue, positioning column are equipped with to realize positioning in binding site.Elastic block tongue, positioning column are according to canIt needs that many places are arranged.
Preferably, the distal end of the ontology is connected with front cover body, the front cover body have axially through cavity.
When front cover body further can seal and improve bulk strength, especially ontology using separate structure, front cover bodyIt can be using being threadedly engaged between the front end of ontology, the cavity of front cover body is for wearing outer sheath and core-pipe subassembly.
Preferably, the cavity length of the front cover body is greater than or equal to the length in gib block hole.
The length in gib block hole determines the movement travel of push rod, and the cavity of front cover body has enough length, Ke YibaoSufficient space when demonstrate,proving pushrod movement, avoids interference with or influences the axial movement of push rod.
Preferably, instruction area is provided in the rotating handle, for checking the movement travel of push rod.
Instruction area can determine the position of push rod by the way of hollow out or local transparent by the position of STATEMENT OF FEDERALLY SPONSOREDAnd stroke.Indicate that the position in area is corresponding to the motion path of STATEMENT OF FEDERALLY SPONSORED.
Preferably, second control mechanism includes being docked at the rear cover body of body proximal end side and being mounted on rear cover bodyThe mutually matched locking mechanism between ontology；The rear cover body have and ontology against fixed bit and be detached from ontology axisTo sliding position, the proximal lateral of the core-pipe subassembly is connected on rear cover body.
Using being detachably connected between rear cover body and ontology, when separation can rapid axial movement realize the fast of core-pipe subassemblyAdjust, rear cover body in conjunction with ontology after be kept fixed by locking mechanism.Axial sliding position is interpreted as the separation shape between ontologyState, it can implement axial sliding, do not limit specific axial position.
Preferably, the push rod have axially through push rod inner cavity, the core-pipe subassembly through the push rod inner cavity simultaneouslyIt is connected on rear cover body.
Push rod uses hollow structure, and core-pipe subassembly of being more convenient for connects, i.e., the epitheca being connected with push rod is penetrated via push rodIn pipe.
Preferably, the rear cover body be equipped with pull rod, the pull rod have axially through pull rod inner cavity, the core pipe groupPart is through the pull rod inner cavity and is connected on rear cover body.
After separating between rear cover body and ontology, core-pipe subassembly may be exposed to outside, be mentioned by the pull rod for being arranged hollowFor the protection to core-pipe subassembly, support is in addition also provided in mechanical strength.
Preferably, the distal side of the pull rod extends into push rod inner cavity.
Preferably, the rear cover body is equipped with the mounting groove towards distal end side opening, the proximal lateral of the pull rod is fixedIt is plugged in the mounting groove.
Preferably, the outer wall of the pull rod is equipped with the positioning convex ring matched with mounting groove inner wall.
Pull rod both ends cooperate with push rod inner cavity and rear cover body respectively, and pull rod slides with respect to the axial direction of rear cover body in order to prevent,It is equipped with positioning convex ring in the outer wall of pull rod, is received in mounting groove inner wall setting locating slot and limits positioning convex ring.
Preferably, the locking mechanism includes the latch hook being mounted on rear cover body and is located on ontology and latch hook matchingThe locked groove of conjunction.
Latch hook can be caught in and be maintained in locked groove by natural resiliency, also can use elastic component and be maintained in locked groove,Offset on rear cover body with body proximal end locked groove cooperation, only keeps relative position by locking mechanism, convenient for rapid axial after unlockRelative motion.
Preferably, being equipped with installation room in rear cover body, the latch hook, which has, is in the indoor tail portion of installation and extensionThe head that installation room is matched with locked groove out is equipped with the driving spring that driving latch hook is caught in locked groove in installation room.
Positioning column or locating slot can be set on latch hook and installation room, two end caps of driving spring are fixed in positioning column or mergingIn the slot of position, the stabilization of driving spring can be kept, avoids misplacing.
Preferably, being equipped with the opening being connected to the installation room on the outer wall of rear cover body, which is embedded withWith the release the lock button of latch hook linkage.
Release the lock button a part is exposed to the outer wall of rear cover body, and convenient for operation control latch hook, shape and the release the lock of opening are pressedButton is adapted, and slip-resistant texture can also be arranged on release the lock button.
Preferably, being the cooperation that offsets between the latch hook and release the lock button, seperated being fixedly connected or integral structure.
Preferably, the rear cover body is seperated fastening structure, seperated part is that at least two valves are in push rod axis respectivelySide, mutually matched grafting positioning element is equipped between adjacent petals.
In seperated fastening structure, the latch hook and release the lock button, the corresponding positions on corresponding ontology are can be set in every valveIt sets and locked groove is respectively set.
Compared with prior art, the present invention the outer sheath, the epitheca with the outer sheath and intervention heart valveCircumferential direction of the conveying device due to the hollow-out unit on the first segment in the distal end of the first segment is disconnected from each other.First segment can be suitableIt answers the internal layer and outer layer and expands, to have foot while making the distal end of the outer sheath with better scalabilityEnough axially and radially support forces, and hollow-out unit is in rounding state, to further provide for enough axial directions and diameterTo support force.So that enough axially and radially support forces are provided, so as to be given an account of in intervention heart valve removal processEnter heart valve fast, safely to recycle.
Outer sheath is driven in the present invention by the way of being threadedly engaged, drives core-pipe subassembly in an axially slidable way, it is realThe combination for having showed fast tune and having adjusted slowly, in addition will drive the first control mechanism of outer sheath to be arranged in the middle part of the axial direction of ontology and more holdsThe control of easy-to-hold drives the second control mechanism of core-pipe subassembly to be located at the proximal lateral of ontology, and when recession does not have with other componentSpace interference, it is convenient to use.
In the present invention outer sheath is reduced using floating position-limiting item to a certain extent and intervenes valvular contact surfaceProduct, also be used as smooth track, reduce two-by-two contact when relative friction forces, during outer sheath is pushed forward and is withdrawn can by withFloating position-limiting item contact reduce doctor operation when direct active force, thus realize to valve bracket release with recycle it is accurateControl.It further can be combined with fixed guide item, operation consent outer sheath collects valve bracket, fixed guide item and valve branchFrame is close to.In subsequent valve bracket release, fixed guide item provides light between outer sheath tubular shell and valve bracketRail reduces contact friction, convenient for the release and control of valve bracket.
Detailed description of the invention
Fig. 1 is the structural schematic diagram of subject delivery system；
Fig. 2 is the structural schematic diagram of subject delivery system distal site；
Fig. 3 is the structural schematic diagram for latching position；
Fig. 4 is the structural schematic diagram of floating position-limiting end；
Fig. 5 a is intervention heart valve part release conditions figure；
Fig. 5 b is the state diagram that floating position-limiting item discharges procedure division release in heart valve；
Fig. 5 c is the state diagram intervened when heart valve discharges completely；
Structural schematic diagram when Fig. 6 is using shorter floating position-limiting；
Fig. 7 a is using the structural schematic diagram before another intervention heart valve release；
Fig. 7 b is the structural schematic diagram (opposite Fig. 7 a, eliminate part outer sheath) before Fig. 7 a intervenes heart valve release；
Fig. 8 is structural schematic diagram when being also equipped with fixed guide；
Fig. 9 is outer sheath schematic cross-section；
Figure 10 a is state diagram before intervention heart valve when being equipped with floating position-limiting item and fixed guide discharges completely；
Figure 10 b is state diagram before intervention heart valve when being equipped with floating position-limiting item and fixed guide discharges completely(opposite Figure 10 a, eliminate part outer sheath)；
Figure 11 a is the schematic diagram that engaging lug matches position with fixing head；
Figure 11 b is the engaging lug of Figure 11 a by the schematic diagram after being pressed on floating position-limiting item；
Figure 12 a is the schematic diagram that another engaging lug matches position with fixing head；
Figure 12 b~Figure 12 d is the engaging lug of Figure 12 a by the schematic diagram for being pressed on different shape floating position-limiting item；
Figure 13 a~Figure 13 d is another engaging lug by the schematic diagram for being pressed on different length floating position-limiting item；
Figure 14 is the structural schematic diagram of conveying device provided by the invention；
Figure 15 is the structural schematic diagram at delivery device distal position provided by the invention；
Figure 16 is the structural schematic diagram of outer sheath provided by the invention；
Figure 17 is the schematic cross-section of delivery conduit provided by the invention；
Figure 18 is intervention heart valve structural schematic diagram provided by the invention；
Figure 19 is the schematic cross-section of outer sheath provided by the invention；
Figure 20 is the structural schematic diagram of the second middle layer provided by the invention；
Figure 21 is the structural schematic diagram at another visual angle of the second middle layer provided by the invention；
Figure 22 is the flaring state structural schematic diagram of the structure of the second middle layer provided by the invention；
Figure 23 is the second middle layer distal structure schematic diagram provided by the invention；
Figure 24 is the schematic enlarged-scale view in Figure 21 provided by the invention at E；
Figure 25 is the schematic enlarged-scale view in Figure 24 provided by the invention at F；
Figure 26 provides the second middle layer distal end another example structure schematic diagram for the present invention；
Figure 27 is the structural schematic diagram of handle in subject delivery system；
Figure 28 is the A-A cross-sectional view of handle part in Figure 27；
Figure 29 is the explosive view of handle in subject delivery system；
Figure 30 is the structural schematic diagram of rotating handle in Figure 29；
Figure 31 is the structural schematic diagram of the section components of ontology in Figure 29；
Figure 32 is the structural schematic diagram of push rod in Figure 29；
Figure 33 is the structural schematic diagram of release the lock button in Figure 29；
Figure 34 is the structural schematic diagram of another angle of release the lock button in Figure 33；
Figure 35 is the structural schematic diagram of rear cover body in Figure 29.
Specific embodiment
Below in conjunction with drawings and examples, the present invention is described in detail.It should be appreciated that described herein specificEmbodiment only to explain the present invention, is not intended to limit the present invention.Proximal end described in text refers to along transportation system by near operationThe one end in person direction, the distal end are one end along transportation system far from operator direction, in embodiment intervention heart valve withFor valve bracket.
Referring to Fig. 1, the present invention includes seeker 2, core-pipe subassembly 7, floating position-limiting item 1, consolidates convenient for the transportation system manipulatedDetermine first 3, interior sheath 4, outer sheath 5 and handle 6.
Seeker 2 and fixing head 3 are each attached on core-pipe subassembly 7, and wherein seeker 2 is located at the distalmost end of core-pipe subassembly 7,7 distal side of core-pipe subassembly is also arranged with fixing head 3, is intervention heart valve installation position between seeker 2 and fixing head 3；EpithecaPipe 5 be in intervention heart valve installation position periphery and can slide axially, the proximal end of core-pipe subassembly 7 and outer sheath 5 with handle 6It is connected, the sliding axially relative to core-pipe subassembly 7 of outer sheath 5 can be realized by handle 6, in addition interior sheath 4 is set as needed,Also it can be omitted, 4 sets of interior sheath is on core-pipe subassembly 7 and is located at 3 proximal lateral of fixing head, and interior sheath 4 is general not with outer sheath 5It is axially moved, when core-pipe subassembly is made of stainless steel, interior sheath is it is also assumed that be overlay film in 7 outer surface of core-pipe subassemblyCoating layer.
Core-pipe subassembly 7 can be also possible to be plugged and fixed by two sections and be linked to be with single part, and plugging position is preferably placed at fixationTo guarantee the smooth of bonding strength and appearance in first 3.
Floating position-limiting item 1 is isometric three in Fig. 1, is successively arranged in the circumferential, the case where no outer sheath 5 fettersIt is stretched naturally in release conditions down.
Referring to fig. 2, the different parts of floating position-limiting item 1 can be divided into starting point 103,102 and of extended segment according to present positionThe proximal lateral of fixed head-tail 32 is fixed on core-pipe subassembly 7 and is in end 101, starting point 103, visible in figure to be located at interior sheathBetween pipe 4 and fixed head-tail 32.Starting point 103 can certainly be arranged on core-pipe subassembly 7, for example be arranged in fixing headOn core-pipe subassembly 7 between the proximal lateral of tail portion 32 and the distal side of interior sheath 4.The periphery of fixing head 3 is equipped with locating slot, due toLocating slot needs and intervenes valvular engaging lug cooperation, therefore its position and shape can match with engaging lug, figureThere are three middle locating slots and axial position interlaced arrangement, such as locating slot 31 and locating slot 33 in figure, in order not to as blockingThe extension of floating position-limiting item 1, locating slot are used axially through structure, and engaging lug radially extends out disengaging positioning when valve bracket dischargesSlot, thus locating slot radial outside be it is open, that is, have radial opening.
Alar part of the locating slot axially through, two sides with extension in figure, to cooperate the engaging lug of T shape, floating position-limiting item 1 toBy corresponding locating slot axially through position when distal end extends, the floating position-limiting item 1 in Fig. 2 is in loading condition.
Bonding can be used in the starting point 103 of floating position-limiting item, binding, lock, welding, integrated mode are fixed.It is viscousCondensation material selects the anticorrosive glue crosslinking agent with biocompatibility.Binding material selects that flexibility is strong, corrosion resistant wiring.
Welding manner can be connected to fixed head-tail or core-pipe subassembly will latch made of alloy material, then pass through lockBanding starting point is detained, for example, see Fig. 3,103 banding of starting point of floating position-limiting item 1 is in the lock of stainless steel (material 306)In 14, part extended segment 102 is only illustrated in figure, lock 14 is connected in a welding manner on fixing head 3 or core-pipe subassembly 7.
Floating position-limiting item 1 is the solid or hollow structure of strip, uses solid flat bar, end 101 in the present embodimentIn order to avoid the outer rim structure (referring to fig. 4) of arc can be used in corner angle.
Every floating position-limiting item 1 a length of 10mm-80mm, wide 1-2mm, thick 0.2-0.5mm.When floating position-limiting item 1 has mostWhen long length, whole can guarantee of floating position-limiting item 1 is convergent in outer sheath 5.
In conjunction with Fig. 5 a and Fig. 5 b, to guarantee that floating position-limiting item 1 has lesser dynamic friction factor, floating position-limiting item 1 is selectedPolytetrafluoroethylene material is fabricated；Every floating position-limiting item 1 is 15mm long in figure, the positioning groove width phase of width and fixing head 3It adapts to, thickness 0.5mm, when floating position-limiting item 1, which is in, collects state, three floating position-limiting items 1 are corresponding axially through positionLocating slot and further extend towards distal end, valve bracket 8 is with there are three the engaging lugs 81 of T shape, in order to adapt to engaging lug shape,Locating slot on the basis of T shape axially through, that is, be in crosswise, in order to guarantee limit effect, locating slot axially through regionIt is completely enclosed by corresponding floating position-limiting item 1, i.e., 1 width of floating position-limiting item is adapted with axially through peak width, if perforationRegion is not along the wide extension of axis, then 1 width of floating position-limiting item is at least corresponding to perforation region most narrow portion position, to guaranteeLocating slot is partially or completely sunk to, the outside of floating position-limiting item 1 can be slightly higher than the outer peripheral surface of fixing head 3, to reduce fixing head 3Friction between 5 inner wall of outer peripheral surface and outer sheath.
When valve bracket 8 is loaded into transportation system, floating position-limiting item 1 is wrapped in valve bracket 8 and is collected together in outerIn sheath 5；During valve bracket 8 discharges, as shown in Figure 5 a, along the direction arrow M, outer sheath 5 is along floating position-limitingItem 1 (floating position-limiting item is in epitheca 5 in figure, thus is not drawn into) is smooth to be withdrawn, and floating position-limiting item 1 is in work shape at this timeState: when bracket engaging lug 81 is in outer sheath 5, due to the constraint of outer sheath 5, floating position-limiting item 1 acts on bracket engaging lugOn 81, the pop-up of bracket engaging lug 81 is prevented.Then, as shown in Figure 5 b, withdrawing further along arrow M with outer sheath 5,The end 101 of floating position-limiting item 1 is detached from the constraint of outer sheath 5, extended segment 102 and bracket engaging lug still in outer sheath 5, thisWhen extended segment 102 act on bracket engaging lug 81, engaging lug 81 overcomes bracket in self-expanding because of the effect of extended segment 102The huge expansive force generated during release, is securely fastened in the locating slot 33 of bracket fixing head 3.If finding valve at this timeReleasing position inaccuracy can recycle bracket by the outer sheath 5 that moves ahead, to be discharged again.Finally, when determination is worked asWhen preceding releasing position is accurate, as shown in Figure 5 c, continues on arrow M and withdraw outer sheath 5,101 He of end of floating position-limiting item 1Extended segment 102 no longer by the constraint of outer sheath 5, the end 101 and extended segment 102 of floating position-limiting item 1 with valve bracket 8 expansionAnd be unfolded, floating position-limiting item 1 is in off working state at this time, i.e., does not apply force on engaging lug 81, to complete valveThe release of bracket 8.
The active force that floating position-limiting item 1 applies bracket engaging lug, on the one hand from the constraint of outer sheath, in an other sideFace, due to fixed against fixing head 3, the extended segment 102 of neighbouring starting point 101 is originated for the starting point 103 of floating position-limiting item 1The binding force at end 103, when the engaging lug of valve bracket 8 is embedded into the locating slot 33 of fixing head 3,1 proximal end of floating position-limiting itemLocating slot 33 is close in extended segment, gives one radially inward pressure of engaging lug of valve bracket 8, can prevent valve bracket 8 from existingThe premature locating slot 33 for being detached from fixing head 3 of engaging lug during release and cause valve bracket 8 to discharge suddenly, while in valveDuring bracket 8 discharges, if the problems such as discovery deviations needs to place again, since 1 proximal end of floating position-limiting item is to predeterminedThe binding force of engaging lug in the slot 33 of position, it is ensured that outer sheath 5 is pushed forward along floating position-limiting item 1, to the part valve branch dischargedFrame 8 is collected, to realize the recycling of valve bracket 8.
Referring to Fig. 6, in other embodiments, 1 axial length of floating position-limiting item is shorter, and end and 3 distal end of fixing head are neatIt is flat.
Floating position-limiting item 1 is between the engaging lug and outer sheath 5 of valve bracket 8 and between outer sheath 5 and fixing head 3Smooth track is provided, relative friction forces when contacting two-by-two are reduced, during outer sheath 5 is pushed forward and withdraws can by with floatingThe contact of positive stop strip 1 reduces direct active force when doctor's operation, to realize the accurate control to valve bracket 8 release and recyclingSystem.
Floating position-limiting item 1 is three solid strips in Fig. 6, and is made of polytetrafluoroethylene material, and floating position-limiting item 1 risesBeginning is fixed on the proximal end tail portion of fixing head 3 by bonding mode, and the end of floating position-limiting item 1 is flushed with 3 distal end of fixing head, i.e.,Engaging lug position can be at least completely covered and be limited in locating slot, 1 width of floating position-limiting item and locating slot 33 axially throughThe equivalent width in region, thickness 0.5mm.
The structural schematic diagram before valve bracket discharges completely is shown in conjunction with Fig. 7 a, 7b, Fig. 7 a, in fig.7b, in order to clearChu shows the structure between the engaging lug 81 and floating position-limiting item 1 of valve bracket 8, is omitted in fig.7b positioned at floating position-limiting item1 and fixing head 3 outside part outer sheath 5.In the present embodiment, valve bracket 8 has engaging lug 81, when valve bracket 8 fillsWhen being downloaded in transportation system, the length that floating position-limiting item 1 extends is suitable with 3 remote location of fixing head, and end is only capable of compressing embeddingEnter the engaging lug inside fixing head locating slot 33.When valve bracket 8 is transported to human body and discharges, outer sheath 5 is dropped back, valve branchFrame 8 gradually discharges.At this point, the engaging lug 81 of valve bracket 8 is embedded into the locating slot 33 of fixing head, engaging lug is by floating position-limitingThe power effect that collects of 1 starting point of item is firmly strapped in locating slot 33, avoids having discharged what valve bracket 8 applied engaging lug endIt extends out power and makes the premature complete release of bracket.
Using the floating position-limiting item 1 of shorter size, the influence and unnecessary constraint normally discharged to bracket can avoid, floatThe length of dynamic positive stop strip 1 can also extend to the axial central region of valve bracket 8, such as valve when discharging completely no more than valvePoint A at the full-size of film axial direction, such as in Fig. 5 c.
Referring to Fig. 8 and Fig. 9, in other embodiments, the distal end inner wall of outer sheath 5 is additionally provided with fixed guide item 51.
In figure in addition to illustrating floating position-limiting item 1, seeker 2, fixing head 3, interior sheath 4, outer sheath 5, valve bracket 8,It is additionally provided with fixed guide item 51 in the inner wall of outer sheath 5, fixed guide item 51 is isometric three, circumferentially uniformly arrangement, andIt is fixed on 5 distal tubular shell inner surface of outer sheath, provides smooth track between valve bracket 8 and outer sheath 5.
The circumferential position and the locating slot in fixing head 3 of each fixed guide item 51 (i.e. floating position-limiting item 1 is circumferentially distributed)It is staggered, when outer sheath 5 collects valve bracket 8, fixed guide proximal end abuts fixing head 3, and position and locating slot are one by oneStaggeredly.
Fixed guide item 51 is solid flat bar, length 10mm-80mm, width 1-2mm, thickness 0.2-0.5mm, this implementationThe length about 60mm corresponding to 8 axial length of valve bracket of fixed guide item 51 in example.
Fixed guide item 51 is fixed using bonding, binding, lock, welding or fixed 5 inner wall of outer sheath of integrated modeGib block 51 is polytetrafluoroethylene material, and the position cooperated with intervention heart valve 8 is with smooth surface and/or there is lubrication to applyLayer.Under best implementation, the inner wall of fixed guide item 51 and outer sheath 5 is integrally formed, and fixed guide item 51 is to epithecaThe projecting inward fin of pipe 5 with smooth surface and/or has lubricant coating.
In conjunction with Figure 10 a, 10b, Figure 10 a shows intervention heart valve when being equipped with floating position-limiting item and fixed guideRelease conditions figure saves in figure 10b in order to clearly show that the structure between the engaging lug 81 of valve bracket 8 and floating position-limiting item 1The part outer sheath 5 outside floating position-limiting item 1 and fixing head 3 is omited.When valve bracket 8 discharges, outer sheath 5 passes through solidDetermine gib block 51 and 8 contact slide of valve bracket, outer sheath 5 can be withdrawn in the case where frictional force very little and realizes bracket graduallyRelease.
When outer sheath 5 withdraws the position of fixing head 3, valve bracket 8 only has engaging lug and is packed in outer sheath 5.At this point, fixed guide item 51 is completely disengaged with valve bracket 8, floating position-limiting item 1 is pressed on engaging lug by collecting for outer sheath 5On.Continue to withdraw outer sheath 5, floating position-limiting item 1 is gradually reduced the power that collects of engaging lug, and engaging lug gradually discharges.To sum up, valveThe smooth track and the realization of radially inward compaction forces that membrane support 8 is provided by fixed guide item 51, floating position-limiting item 1 are gradually releasedIt puts.
As a further improvement of the present invention, in other embodiments, floating position-limiting item a part setting is solidDetermine on/within the locating slot of head, plays limit bracket fixed ear and radially extend out disengaging locating slot, another part is arranged outside fixing headOn peripheral wall, play the role of sliding rail, outer sheath is slided along this floating position-limiting item.It is corresponding with locating slot floating under best modeDynamic positive stop strip distalmost end and fixing head are aligned or are no more than fixing head distalmost end or only slight beyond fixing head distalmost end.
Following embodiment is mainly for the length and shape and engaging lug of floating position-limiting item and the cooperation of fixing headMode is described further, and related other component can be employed or in combination at least one of aforementioned each embodiment.
Referring to Figure 11 a and Figure 11 b, engaging lug 81 is T shape, and the positioning region in fixing head 3 is locating slot 33, intervenes heart valveAfter film loads, engaging lug 81 is inlaid in the corresponding locating slot 33 of shape, and floating position-limiting item 1 is laminated on company by the constraint of outer sheathOn lug 81, to prevent engaging lug 81 from deviating from from locating slot 33, during bracket is released, when outer sheath completely disengages floating limitWhen the item 1 of position, the limit of engaging lug 81 is just released.
Referring to Figure 12 a~Figure 12 d, engaging lug 81 is U-shaped, and U-shaped opening side is connected with bracket, and U-shaped opening is closed,Positioning region in fixing head 3 is positioning plush copper 34, and engaging lug 81 is hung in positioning plush copper 34 using U-shaped structure, it can be achieved that axialPositioning, in order to avoid the excessively diameter convex of engaging lug 81 is equipped with sedimentation in the outer wall of periphery, that is, fixing head 3 of positioning plush copper 34Slot 35, engaging lug 81 are stacked in subsider 35, can be realized with the outer wall of fixing head 3 radially contour.
In Figure 12 b, floating position-limiting item 1 is bifurcation structure, i.e. U-shaped, non-bifurcation is fixed on the outside of fixing head 3, pointFork position is laminated on the outside of engaging lug 81 to distally extending up to.
In Figure 12 c, floating position-limiting item 1 is single strip structure, is equally also laminated on engaging lug 81 to distally extending up toOutside.
In Figure 12 d, floating position-limiting item 1 is bifurcation mechanism, but uses V-arrangement or Y shape, and non-bifurcation is fixed on fixing head 3Outside, bifurcation is laminated on the outside of engaging lug 81 to distally extending up to.
Referring to Figure 13 a~Figure 13 d, it is shown that structural schematic diagram of the engaging lug by the floating position-limiting item 1 for being pressed on different length.When intervening heart valve loading condition, outer sheath 5 fetters floating position-limiting item 1, and engaging lug 81 is positioned to the outside of fixing head, fixedFor positioning region on head is in the way of positioning plush copper 34, the distal side of floating position-limiting item 1 is at least partly laminated on engaging lug 81On.
The distal side of the visible floating position-limiting item 1 of Figure 13 a is laminated on engaging lug 81, and the distal side of floating position-limiting item 1 is not yetPositioning plush copper 34 is extended to, the fraction region of engaging lug 81 is only laminated.
The distal side of the visible floating position-limiting item 1 of Figure 13 b is laminated on engaging lug 81, and the distal side of floating position-limiting item 1 is in axisThe positioning region being upwardly into major general's fixing head is completely covered, that is, has crossed positioning plush copper 34, reaches the distal side of fixing head 3,Axis laminates engaging lug 81 and entire fixing head 3 up towards distal end side.
The distal side of the visible floating position-limiting item 1 of Figure 13 c is laminated on engaging lug 81, and the distal side of floating position-limiting item 1 is in axisUp over fixing head.
The distal side of the visible floating position-limiting item 1 of Figure 13 d is laminated on engaging lug 81, and the distal side of floating position-limiting item 1 is in axisUp over fixing head, the intervention maximum position of heart valve diameter is reached, is intervened after heart valve loads due to by epithecaTube bank is tied up, and it is almost the same to intervene valvular outer diameter, therefore the maximum position of diameter can be regarded as under release conditions diameter mostBig position.
Following embodiment is illustrated mainly for the improvement of outer sheath, and related floating position-limiting item or other component canTo be employed or in combination at least one of aforementioned each embodiment.
Referring to Figure 14 and Figure 18, conveying device 100 is to convey intervention heart valve 82 to the corresponding position of human body.InstituteThe intervention heart valve 82 stated can be valve bracket or the bracket of its type.
The conveying device 100 includes core-pipe subassembly 10, epitheca 20, handle 30, the core-pipe subassembly 10 and the handle30 connections, the epitheca 20 are slidably sheathed on the core-pipe subassembly 10, and the epitheca 20 is located at the core-pipe subassembly 10 and instituteIt states between handle 30.The intervention heart valve 82 is loaded on the core-pipe subassembly 10, and is housed in the epitheca 20.InstituteIt states handle 30 and axially moves ahead or withdraw to control the relatively described epitheca 20 of the core-pipe subassembly 10, so that the intervention heartThe release of valve 82 or recycling.
The core-pipe subassembly 10 includes core pipe 11, seeker 12.The proximal end of the core pipe 11 is connect with the handle 30, instituteThe distal end for stating core pipe 11 is pierced by from the epitheca 20 and connect with the seeker 12.Herein, it is to be understood that it is described closeEnd is that in contrast, specifically, the proximal end, which refers to, leans on the one of proximal operator direction along the conveying device 100 with the distal endEnd, the distal end are along the described one end of conveying device 100 far from operator direction.
Referring to Figure 15, the core pipe 11 includes middle pipe 111 and loading section 112.The proximal end of the middle pipe 111 and the handHandle 30 connects, and the distal end of the middle pipe 111 is equipped with fixing head 1111 and floating position-limiting item 1112.The fixing head 1111 is usedIt is matched in the intervention heart valve 82 fixed heart valve 82 will be intervened.The loading section 112 is located at the fixing headBetween 1111 and the seeker 12, the proximal end for loading section 112 is retained in the fixing head 1111, the loading section112 distal end is connect with the seeker 12, and the loading section 112 is located in the epitheca 20, and the loading section 112 is used forLoad the intervention heart valve 82.
Further, the floating position-limiting item is greater than the fixing head 1111 described in the axial length of the core pipe 11The axial length of core pipe 11.
Bonding can be used in the floating position-limiting item 1112, binding, lock, welding, integrated mode are retained on the middle pipeOn 111.The floating position-limiting item 1112 reduces epitheca 20 to a certain extent and intervenes the contact area of heart valve 82,As smooth track, reduces epitheca 20 and intervene relative friction forces when heart valve 82 contacts, it is relatively described outer in core pipe 11Sheath 20 can reduce direct work when doctor's operation by the contact with floating position-limiting item 1112 during axially moving ahead or withdrawFirmly, to realize the accurate control to intervention heart valve 82 release and recycling.
Referring to Figure 16, epitheca 20 is usually formed as tubular structure, epitheca 20 have certain flexibility, axial support force withAnd radial support power.Including delivery conduit 21, coupling tube 22 and outer sheath 23, the proximal end of the delivery conduit 21 and the handHandle 30 connects, and the distal end of the delivery conduit 21 is connect with the outer sheath 23.The inside of the delivery conduit 21 and described outerThe inside of sheath 23 is connected to setting.The coupling tube 22 is equipped between the delivery conduit 21 and the outer sheath 23, it is described defeatedIt send and is interconnected between conduit 21 and the outer sheath 23 by the coupling tube 22.The core pipe 11 sequentially passes through the conveyingConduit 21, coupling tube 22 and outer sheath 23.
The intensity of the distal end of the delivery conduit 21 is sequentially increased from the delivery conduit 21 to 23 direction of outer sheath.To make the delivery conduit 21 have it is certain it is flexible simultaneously, but also with axial support force, make the delivery conduit 21It can satisfy different implantation points.The diameter of the delivery conduit 21 is less than the diameter of the outer sheath 23.
Referring to Figure 17, the delivery conduit 21 includes three-decker.Specifically, the delivery conduit 21 includes along described defeatedSend 21 radial direction of conduit that the first internal layer 211, the first middle layer 212 and the first outer layer 213 are successively set from the inside to the outside.It is describedA variety of combinations can be used between first internal layer 211, first outer layer 213 and first middle layer 212.For example,Pass through heat fusing or binder mode between first internal layer 211, first outer layer 213 and first middle layer 212Connection；Or first internal layer 211, first outer layer 213 are realized and the first middle layer by immersion liquid or spray coating mode212 connection.First internal layer 211 and the first outer layer 213 can be using the profits of identical or different high molecular materialSliding elastomer so that the delivery conduit 21 have it is certain it is flexible simultaneously, but also with enough axial support forces, also haveStandby sliding capability.To even if there is tortuous implantation site (for example, working as edge during implantation intervenes heart valve 82When the moving body arch of aorta is bent) it can also complete accurately to be implanted into.PTFE can be used in first internal layer 211(Polytetrafluoroethylene, polytetrafluoroethylene (PTFE)), PEBAX (Polyeher block amide, polyether block amide)Equal high molecular materials, first outer layer 213 is using PTFE, PU (Polyurethane, polyurethanes, referred to as poly- ammoniaEster), Pebax (A Kema nylon elastomer), the materials such as PE (polyethylene).In the present embodiment, first internal layer 211 withAnd first outer layer 213 is using the lubrication elastomer of identical high molecular material, including PTFE(Polytetrafluoroethylene, polytetrafluoroethylene (PTFE)) or PEBAX (Polyeher block amide, polyether block acylAmine).
First middle layer 212 is formed using metal braid or by cuts in metallic pipe, to make the delivery conduit21 are able to maintain certain axial support force in the case where having certain flexible situation again.Preferably, first middle layer 212 usesCuts in metallic pipe forms.
Coupling tube 22 is used to connect the transition between the delivery conduit 21 and the outer sheath 23.Further, instituteThe section for stating coupling tube 22 is trapezoidal.The structure of the coupling tube 22 is identical as the structure of the outer sheath 23.
After valve loading, the loading section 112 is contained in the outer sheath 23, the outer sheath 23 is to accommodateIt gives an account of into heart valve 82.Before discharging the intervention heart valve 82, the intervention heart valve 82 is in mixture of ice and waterIt is middle to be accommodated in the outer sheath 23 by compression.Herein, it is to be understood that referring to Figure 18, the intervention heart valve 82Including bracket 83 and valve, the valve is by manually sewing on the bracket 83.The bracket 83 uses NitinolBracket, the valve is using the production of the biomaterials such as Pigs Hearts packet, bovine pericardium.The nick-eltitanium alloy stent has shape memory functionCan, soften in mixture of ice and water, thus be easily folded in the outer sheath 23 by compression, when discharging in blood, expansionRestore shape when its expansion.
During release, by operation handle 30, so that the outer sheath 23 is axially moved with respect to core pipe 11, release is situated betweenEnter heart valve 82, during this, once the releasing position of the discovery intervention heart valve 82 is not just, by handle 30,So that outer sheath 23 moves ahead with respect to mandrel, the part of 23 distal end of outer sheath is set gradually to wrap up intervention heart valve 82, in outer sheathUnder 23 binding force (adjacent circumferential expansion resistance) effect, compresses the intervention heart valve 82 and be recycled in outer sheath 23.
Referring to Figure 19, the axis of the outer sheath 23 and the axis of the delivery conduit 21 and the axis weight of coupling tube 22Close setting.The outer sheath 23 includes three-decker.Specifically, the outer sheath 23 includes along 23 radial direction of outer sheathSecond internal layer 23a, the second middle layer 23b and the second outer layer 23c are successively set from the inside to the outside.It is the second internal layer 23a, describedA variety of combinations can be used between second middle layer 23b and the second outer layer 23c.For example, the second internal layer 23aAnd it is connected between the second outer layer 23c and the second middle layer 23b by heat fusing or binder mode.Described secondInternal layer 23a and the second outer layer 23c can be using the lubrication elastomer of identical or different high molecular material, so that described outerSheath 23 have it is certain it is flexible simultaneously, but also with enough axial support forces, be also equipped with sliding capability.In described secondLayer 23a can use PTFE (Polytetrafluoroethylene, polytetrafluoroethylene (PTFE)) high molecular material, and the second outer layer 23c canUsing using PTFE, PU (Polyurethane, polyurethanes, abbreviation polyurethane), Pebax (A Kema nylon elasticBody), the materials such as PE (polyethylene).In the present embodiment, the second internal layer 23a and the second outer layer 23c is using phaseThe lubrication elastomer of same high molecular material, including PTFE (Polytetrafluoroethylene, polytetrafluoroethylene (PTFE)).
0 and Figure 21 referring to fig. 2, the second middle layer 23b are enhancement layer, and stainless steel tube or Nitinol pipe can be usedIt cuts, Nitinol pipe can also be used in first segment, rest part uses stainless steel tube.The second middle layer 23b is usedTo improve the axial support force, radial support power, binding force (adjacent circumferential expansion resistance) and the flexibility that include the outer sheath 23Deng providing enough binding forces and compress the intervention heart valve 82 in during the withdrawing of heart valve 82 of interventionIn receiving to outer sheath 23.Secondly, axial support force and flexibility that the second middle layer 23b is provided can make the outer sheath 23With good bending property, so as to meet the different implantation sites of human body, realize that the intervention heart valve 82 is implanted into.
Specifically, the second middle layer 23b includes first segment 231, second segment 232 and third section 233.Described firstSection 231, the second segment 232 and the third section 233 are sequentially connected, and the first segment 231 is close to the outer sheath 23Distal end is arranged, and the third section 233 is arranged close to the proximal end of the outer sheath 23, and the second segment 232 is located at the first segment231 and third section 233 centre.
0- Figure 25 referring to fig. 2, the first segment 231 is using including engraved structure, so that the distal end of the outer sheath 23 hasStandby enough radial elastic power and axial support force.The engraved structure is in rounding state along the radial direction of outer sheath 23.It is described to engraveThe hollow-out parts of hollow structure may include diamond shape, rectangular and " drops " etc..
The first segment 231 includes multiple hollow-out units 2311.Multiple hollow-out units 2311 are along the first segment 231Be circumferentially arranged setting, the hollow-out unit 2311 of adjacent two is disconnected from each other in the circumferential distal end of the first segment 231.It can understand, it is described there are hollow out gap L between the circumferential direction of first segment 231 between the adjacent hollow-out unit 2311The range of hollow out gap L is between 0.5mm-8mm.And since the first segment 231 is in the second internal layer 23a and secondBetween outer layer 23c, first segment 231 can comply with the second internal layer 23a and the second outer layer 23c and expand, because of NiTi after expansionSecond middle layer 23b of compo pipe has shape memory function and promotes to reset, to considerably increase 23 distal end of outer sheathThe toughness of radial support power；Meanwhile the hollow-out parts of engraved structure are in rounding state, so that enough axial support forces are provided,It effectively prevents when withdrawing the intervention heart valve 82, the occurrence of the 23 distal end fold of outer sheath；Secondly, allMake 23 distal end of outer sheath that there is the flaring to the outer sheath adjacent circumferential expansion to hollow-out unit 2311 disconnected from each other, thusThere is buffer function when recycling intervention heart valve 82, so that the release and recycling of the intervention heart valve 82It is more smooth, while avoiding intervention 82 fold of heart valve.
In the present embodiment, the first segment 231 includes 4-6 hollow-out unit 2311.The hollow-out unit 2311 existsThe circumferential direction setting disconnected from each other of the first segment 231.Circumferential even circumferential point of the hollow-out unit 2311 along first segment 231Cloth.Axial direction and circumferential not closed diamond shape, the rectangle etc. of distal end are formed between the hollow-out unit 2311 of adjacent twoSpace.
Referring to fig. 26, in other embodiments, the hollow-out unit 2311 in the circumferential direction of the first segment 231 is adjacentTwo hollow-out units 2311 between can form one group of hollow-out unit 2311.And between two groups of adjacent hollow-out units 2311The setting disconnected from each other of the circumferential direction of first segment 231.It is, of course, also possible to be to form one between 3 hollow-out units 2311 successively arrangedGroup hollow-out unit 2311, and in the circumferential direction setting disconnected from each other of first segment 231 between two groups of adjacent hollow-out units 2311.
The hollow-out unit 2311 of adjacent two is disconnected from each other in the circumferential distal end of the first segment 231.AdjacentTwo hollow-out units 2311 are while the circumferential proximal end of the first segment 231 can interconnect or part connectsIt is connect with the second segment 232.
In other embodiments, adjacent two hollow-out units 2311 are in the circumferential close of the first segment 231End is independently arranged mutually, and is connect respectively with the second segment 232, it may be assumed that it is appreciated that in the present embodiment, adjacent twoIt is independently arranged mutually between a hollow-out unit 2311.
At least one hollow hole 2311b is offered in the hollow-out unit 2311, the hollow hole 2311b is along the hollow outUnit 2311 is axial from distally proximally extending.
Further, 2-4 hollow hole 2311b can be offered in the hollow-out unit 2311.Two adjacent hollow holesIt interconnects or is not connected between 2311b, that is, setting is spaced between two adjacent hollow hole 2311b, described with reinforcement2311 structural strength of hollow-out unit, so that hollow-out unit 2311 has enough axially and radially support forces.
In other real modes, opened up in the hollow-out unit 2311 there are two hollow hole 2311b, two hollow holes2311b arranges along the axial of the hollow-out unit 2311 from distal end to proximal end；Or, two hollow hole 2311b are along instituteState being circumferentially arranged for hollow-out unit 2311.In other embodiments, hollow hole there are three being opened up in the hollow-out unit 23112311b, three hollow hole 2311b can be in linear type, and the arrangement modes such as triangular shape are arranged in the hollow-out unit 2311On.It is to be appreciated that the purpose of the arrangement mode of setting hollow hole 2311b and fabric hollow hole 2311b be intended to improve it is describedThe overall structural strength and flexibility of outer sheath, radial direction and axial support force.As long as and can be improved the outer sheathThe arrangement of overall structural strength can be carried out arranging in the present invention, therefore to the arrangement side of hollow hole 2311b in inventionFormula is just with no restriction.
The hollow-out unit 2311 includes at least one hollow out segment 2311a.Offered on the hollow out segment 2311a toA few hollow hole 2311b.Adjacent hollow-out unit 2311 is divided mutually between the hollow out segment 2311a of its distalmost endFrom.Hollow out gap L described engraves hole unit 2311 along axially extending mark off of the hollow out segment 2311a.
Further, the arrangement mode of the hollow hole 2311b on the hollow out segment 2311a can refer to the hollow-out unitThe arrangement mode of hollow hole 2311b on 2311, details are not described herein again.
40%-the 80% of 2311 area of hollow-out unit described in the area station of the hollow hole 2311b.Preferably, described to engrave60%-the 70% of 2311 area of hollow-out unit described in the area station of emptying aperture 2311b.To in the second internal layer 23a, describedWhen heating combination between the second middle layer 23b, the second outer layer 23c, so that in the second middle layer 23b and described secondThe binding force that adherence quality between layer 23a and the second outer layer 23c more preferably, between three layers combines is bigger, and associativity is moreIt is good, further, axial support force, the radial support power of outer sheath 23 are improved, and it is enough flexible to have the outer sheathProperty；Secondly, the area that hollow hole 2311b area accounts for hollow-out unit 2311 is sufficiently large, be conducive to hollow out in hot melt cohesive processGas discharge in the 2311b of hole, further increases the second internal layer 23a, the second middle layer 23b, between the second outer layer 23cBinding force, to enhance the overall structural strength of the outer sheath 23.
The hollow hole 2311b is substantially in " drops ".When setting in the hollow-out unit 2311, there are two hollow hole 2311bWhen, it is substantially in figure of eight structure described in two.
The distal end of 0 and Figure 23 referring to fig. 2, the hollow-out unit 2311 are additionally provided with arc section 2311a1.The arc sectionThe arc of 2311a1 is protruded to the distal end of the hollow-out unit 2311 to be arranged.The arc section 2311a1 and the hollow-out unit2311 surround the hollow hole 2311b.Arc section 2311a1 has inner circle segmental arc and an outer circle segmental arc, and the half of the inner circle segmental arcDiameter range is 0.3mm-1mm, it is preferable that the radius of the inner circle segmental arc is 0.5-0.8mm；The radius of the outer circle segmental arcRange is 1mm-16mm, it is preferable that the radius of the outer circle segmental arc is preferred 0.6-3mm, further preferably 0.7-2mm.The distal end of the grid ontology 2311a not only effectively prevent intervention heart valve 82 to return using the design of arc section 2311a1During removing, situations such as intervention heart valve 82 is punctured, torn by the distal end of first segment 231；Secondly, using arc section2311a1 can provide bigger radial support power, keep the distal radial support force of the outer sheath 23 bigger, thus being given an account ofEnter to be more advantageous to during heart valve 82 is withdrawn and described compress the intervention heart valve 82.
Certainly in other embodiments, hollow hole, two adjacent institutes can be not provided in the hollow-out unit 2311Hollow-out unit 2311 is stated in the circumferential distal end setting disconnected from each other of the first segment 231.
The second segment 232 is to include the overall structural strength and flexibility for improving the outer sheath 23 and providing.InstituteThe axially and radially support force for stating second segment 232 is big than the axially and radially support force of the first segment 231, to mentionFor bigger binding force, to load the intervention heart valve 82.
The second segment 232 includes First Transition section 2321, bending section 2322 and the second changeover portion 2323.Described firstChangeover portion 2321, the bending section 2322 and second changeover portion 2323 are from the distal end of second middle layer 22 to proximal endIt is sequentially distributed.Second segment 232 between the First Transition section 2321 and the first segment 231 by connecting.The First TransitionMultiple connecting hole 2321a are offered in section 2321.The gross area of the connecting hole 2321a accounts for the face of the First Transition section 2321Long-pending 60-70%, to make bonded area when hot melt is combined between second segment 232 and the second internal layer 21a, the second outer layer 23cIt maximizes, while improving the overall structural strength of outer sheath 23, so that the outer sheath 23 is had flexibility, and have enough axisTo and radial support power.
Preferably, the connecting hole 2321a includes round connecting hole 2321a, oval connection hole 2321a, rectangular connectionHole 2321a etc..In the present embodiment mode, multiple round connecting hole 2321a are offered in the First Transition section 2321.It is multipleRound connecting hole 2321a is distributed in the circumferential direction of the First Transition section 2321 evenly and at intervals.
The bending section 2322 increases the circumferential support force of the outer sheath 23 to provide, appropriate axially and radially props upSupport force makes outer sheath 23 meet different implantation points and carries out to prevent the outer sheath 23 from bending or twisting together and overall flexibilityDischarge the intervention heart valve 82.
Further, the bending section 2322 includes the spiral section 2322a being axially distributed along the bending section 2322.It is describedBending section 2322 is formed by helical cut.Spacing between the adjacent spiral section 2322a is t1, the bending section 2322That upper spacing t1 is always t, and the t accounts for the 30-60% of total high (length) of the bending section 2322, and the preferably described t accounts for the bendingThe 40-50% of total high (length) of section 2322.To make to heat knot between bending section 2322 and the second internal layer 21a, the second outer layer 23cBonded area when conjunction maximizes, to make the outer sheath 23 i.e. with flexibility, and has and enough axially and radially props upSupport force.
In other embodiments, the bending section 2322 can be C-ring, and the bending section 2322 is cut by C-shapedIt is cut into C-ring.It is spaced setting between two adjacent C-rings, but does not turn off, it may be assumed that between two adjacent C-rings mutuallyConnection.It is contacted between the C-ring by reinforcing rib 2322a.It further, can be between the two neighboring C-ringIt is to be equally spaced, may not be and be equally spaced, in the present embodiment with no restriction.
Second changeover portion 2323 is to the connection between the bending section 2322 and the third section 233.DescribedMultiple connecting hole 2321a are offered on two changeover portions 2323.Multiple connecting hole 2321a are set, to make the second changeover portionBonded area when hot melt is combined between 2323 and the second internal layer 21a, the second outer layer 23c maximizes, further,Improve outer sheath 23 overall structural strength while, so that the outer sheath 23 is had flexibility, but have it is enough axial direction andRadial support power.
Preferably, in the present embodiment, second changeover portion 2323 offers multiple square attaching apertures 2321a.It is moreA square attaching apertures 2321a is evenly spaced apart to be distributed in the circumferential direction of second changeover portion 2323.It will be appreciated, of course, thatThe square attaching apertures 2321a can not also compartment of terrain be distributed in the circumferential direction of second changeover portion 2323.
The third section 233 extends in the coupling tube 22.The third section 233 includes muti-piece floating piece 2331, institute2331 being provided at circumferentially spaced in the third section 233 of muti-piece floating piece is stated, every piece of floating piece 2331 offers multiple companiesMeet hole 2321a.Herein, the muti-piece floating piece 2331, which is provided at circumferentially spaced, is conducive to described collapse the third section 233In the coupling tube 22, meanwhile, multiple connecting hole 2321a are set on floating piece 2331, so that third section 233 and described secondBonded area when combining is heated between internal layer 21a, the second outer layer 23c to maximize, and further, improves outer sheath 23Overall structural strength.
It in the present invention, is by that can be softened to the cold using Nitinol when being loaded due to the intervention heart valve 82Characteristic is compressed, so that intervention 82 compression loaded of heart valve is in the outer sheath 23 described in mixture of ice and water.WhenDuring the intervention heart valve 82 discharges in human body, heart valve 82 is intervened gradually from the 23 distal end exhibition of outer sheathIt opens.It is envisioned that comparing and mixture of ice and water, the temperature of human body is the temperature of significantly larger than mixture of ice and water, in the mistake of releaseCheng Zhong, the intervention heart valve 82 is equivalent to be heated in human body, and the intervention heart valve 82 is in the outer sheath 23The expansionary force of distal end be very big.When the position inaccuracy that discovery intervention heart valve 82 discharges, it is desirable to will be given an account ofEnter heart valve 82 and re-compress to be recycled in outer sheath 23, the outer sheath 23 just needs sufficiently large axial direction to be offered, diameterTo support force to compress the intervention heart valve 82.
In the present invention, by the way that the second middle layer 23b is arranged in the outer sheath 23, so that described the of outer sheath 23Associativity between two internal layer 23a, the second middle layer 23b and the second outer layer 23c is more preferable, and it is whole to improve outer sheath 23Axial direction, the radial support power of body, while making outer sheath that there is certain flexibility, so that the intervention heart valve 82 recycledSufficiently large axially and radially support force is provided in journey.
Hollow hole 2311b specifically, by the distal end of the second middle layer 23b be arranged first segment 231, described firstCircumferential direction of the hollow-out unit 2311 in 231 distal end of first segment in section 231 separates from each other, to make the remote of the outer sheath 23It holds scalability more preferable, enough axially and radially support forces is provided simultaneously with, further, from the hollow-out unit 2311The gross area of hollow hole 2311b accounts for the 40-80% of the area of the hollow-out unit 2311, it can be seen that in second internal layer23a, the second middle layer 23b, it heats between the second outer layer 23c when combining, the second middle layer 23b made and instituteThe binding force of adherence quality more preferably, between three layers stated between the second internal layer 23a and the second outer layer 23c is bigger, associativityIt is more preferable, and then improve the axial support force of the outer sheath 23, radial support power, and it is enough soft to have the outer sheathToughness.
The course of work of conveying device is described below.
First intervention heart valve 82 is compressed in mixture of ice and water, the loading section being loaded on the core-pipe subassembly 10It 112 and is housed in epitheca 20.After intervention heart valve 82 is delivered to human lesion position, passes through handle 30 and control core pipe group10 opposite segments epitheca 20 of part moves ahead, so that intervention heart valve 82 is unfolded in the self-expanding of the epitheca 20.
When ensuring that intervention 82 releasing position of heart valve is accurate, core-pipe subassembly 10 continues to move ahead, and intervenes heart valve 82Release is deployed in lesion locations, and makes to intervene the disengaging fixing head 1111 of heart valve 82, completes the release of intervention heart valve 82.
If the releasing position of discovery intervention heart valve 82 is not right during release, core pipe group is controlled by handle 30Part 10 is withdrawn, and epitheca 20 provides enough axially and radially support forces during withdrawing, and in the floating position-limiting itemIt compresses the intervention heart valve 82 under 1112 guidance, the intervention machinery 82 is housed in the epitheca 20, i.e., it is completeAt the recycling of the intervention heart valve 82.
Following embodiment is illustrated mainly for the improvement of handle, and related floating position-limiting item or other component can be withIt is employed or in combination at least one of aforementioned each embodiment.
Referring to fig. 27, handle includes the ontology of tubulose, have in ontology axially through inner cavity, be equipped with core pipe in ontologyComponent 500 and the outer sheath 110 for being slidably fitted in 500 periphery of core-pipe subassembly.500 distal end of core-pipe subassembly is equipped with fixing head 510And seeker 520, for loading intervention heart valve between fixing head 510 and seeker 520,110 distal end of outer sheath is hadCapsule 600 (load section) for wrapping up intervention heart valve；When withdrawing outer sheath 110 relative to core-pipe subassembly 500, the heart is intervenedDirty valve intervention heart valve is exposed in vivo and is discharged into blood；Otherwise it moves ahead outer sheath relative to core-pipe subassembly 500110, then it wraps up heart valve prosthesis and enters loading section, recycling intervention heart valve.
Body distal end is equipped with front cover component 300, plays closing and booster action, 110 slide outside of outer sheath is combined with setPipe 100 is connected with sliding seat 700 by locking cap 320 at front cover component 300, and casing 100 is connected with sliding seat 700, releasesAfter the fixation of locking cap 320 and front cover component 300, sliding seat 700 can drive casing 100 to slide axially, and especially be situated between in recyclingWhen entering heart valve, sliding sleeve 100 can be pushed to 600 periphery of capsule, further package tightens capsule 600, prevents intervention heartValve abjection, in order to which safe retrieving accesses instrument.
Fixed the first control mechanism 200 in the handle in 110 proximal end of outer sheath, and slow transfer drive is realized using engagement threadIt is dynamic.The second control mechanism 400 of the connection of core-pipe subassembly 500 in the handle, and realize that fast transfer drive is dynamic using mode in axial sliding.
8~Figure 35 referring to fig. 2, handle include the ontology 220 of tubulose, and the periphery wall of ontology 220 is equipped with axially disposedGib block hole 2230, ontology 220 is separate structure, be made of two valve bodies 2210 fastening, on mutually matched position,Middle one be equipped with positioning column 2260, another one be equipped with the corresponding location hole in position, the two can use be interference fitted etc. modes withFix two valve bodies.
220 both ends of ontology are respectively proximal end 2240 and distal end 2220, are respectively used to and the second control mechanism 400 and front coverComponent 300 is cooperatively connected.
First control mechanism includes；
Push rod 230 in ontology 220, push rod 230 have the body of rod 2310, push rod inner cavity of the body of rod 2310 with perforation2330, the distal side of the body of rod 2310 is for connecting outer sheath 110；
It is fixedly mounted on push rod 230 and extends radially the STATEMENT OF FEDERALLY SPONSORED 2320 in gib block hole 2230；
The inner wall of the rotating handle 210 being sleeved on outside ontology 220, the rotating handle 210 is equipped with and 2320 phase of STATEMENT OF FEDERALLY SPONSOREDThe internal screw thread 2120 of cooperation.
Rotating handle 210 is separate structure, is made of two fastenings of valve body 2110, the binding site of two valve bodies is equipped with phaseThe locating piece mutually cooperated is equipped with positioning column 2140, location hole 2150, another valve body is similarly but position by taking a wherein valve body as an exampleJust complementary, so that the positioning column and location hole on different valve bodies cooperate.Positioning strip 2160 and positioning are additionally provided on valve bodySlot 2170, positioning strip and locating slot on different valve bodies cooperate.
210 outer wall of rotating handle is equipped with anti-skid chequer 2110, and 210 inner wall of rotating handle is in addition to internal screw thread 2120 also close to remoteThe position of end and proximal end is equipped with the annular groove 2130 of axial limiting, correspondingly, being equipped with and annular on the corresponding position of ontology 220The annular convex platform that slot 213 matches, such as a wherein annular convex platform 2250.
Instruction area is provided in rotating handle by the way of hollow out or local transparent, for checking the movement row of push rodJourney.
When needing to adjust outer sheath 110, rotating handle 210 is rotated, drives STATEMENT OF FEDERALLY SPONSORED 2320 along axis by internal screw thread 2120To movement, i.e., push rod 230 drives outer sheath 110 to be axially moved relative to core-pipe subassembly, the characteristics of due to screw-driven, makes this mistakeJourney is slow tune outer sheath.
Front cover component 300 includes the front cover body 310 being plugged and fixed in 220 distal end of ontology, has axial pass through in front cover body 310Logical cavity, and the positioning key 3120 circumferentially positioned with 220 outer wall of ontology is had, 310 outer wall of front cover body is equipped with anti-skid chequer 3110,Locking cap 320 is threadedly connected to the distal side of front cover body 310.The cavity length of front cover body 310, which is greater than or equal to, to be ledTo the length in hole 2230, guarantees sufficient space when push rod 230 moves, avoid interference with.
Second control mechanism 400 include be docked at 210 proximal lateral of ontology rear cover body 41 and be mounted on rear cover body 41 withMutually matched locking mechanism between ontology 210；Using being detachably connected between rear cover body 41 and ontology 210, when separation, can be fastSpeed is axially moved the fast tune for realizing core-pipe subassembly, and rear cover body 41 is kept fixed after being combined with ontology 210 by locking mechanism.
Push rod 230 in first control mechanism have axially through push rod inner cavity 2330, core-pipe subassembly 500 pushes away through thisBar inner cavity 2330 is simultaneously connected on rear cover body 41.
Rear cover body 41 is equipped with the mounting groove 417 towards distal end side opening, is fixedly plugged with pull rod 45 in mounting groove 417,The outer wall of pull rod 45 is equipped with the positioning convex ring 418 matched with 417 inner wall of mounting groove, is used for axially position.
Pull rod 45 have axially through pull rod inner cavity, core-pipe subassembly is through the pull rod inner cavity and being connected to rear cover body 41On, the distal side of pull rod 45 extends into push rod inner cavity 2330.
Rear cover body 41 is separate structure, is fastened by two valves, by taking a wherein valve body as an example, is equipped with positioning column 414, positioningHole 415, another valve body is similarly but position is just complementary, so that the positioning column and location hole on different valve bodies cooperate.Valve bodyOn be additionally provided with positioning strip 412 and locating slot 413, positioning strip on different valve bodies and locating slot cooperate.
The opening 411 for being equipped with installation room 416 on two valve bodies of rear cover body 41 and being communicated with installation room 416, installationRelease the lock button 42 is packaged with by cover board 44 in room 416, driving spring 43 has been compressed between cover board 44 and release the lock button 42.
Release the lock button 42 includes the latch hook 422 of button portion and integral structure, and button portion upper surface has anti-skid chequer 421,It is equipped with positioning column 423 towards the side of installation room, the side of cover board 44 towards installation room also is provided with positioning column, and 43 liang of driving springEnd cap, which is set, to be located on corresponding positioning column.
Latch hook 422 extends rear cover body 41, matches with the locked groove 2270 in 220 proximal face of ontology.
It is corresponding with the aforementioned slow tune process of outer sheath, the second control mechanism 400 can fast aligning tube assembly 500, first pressRelease the lock button 42 link latch hook 422, while compressible drive spring 43, latch hook 422 be detached from locked groove 2270 limitation, at this time afterLid 41 unlocks with ontology 220, pulls rear cover body 41 that can drop back together with core-pipe subassembly 500 and pull rod 45, i.e., relative toOuter sheath 110 is axially moved, due to being that can realize fast tune, when needing to be reset, forward without the axial movement of other limitationsRear cover body 41 is pushed, until latch hook 422 is caught in locked groove 2270.
The embodiment of the present invention be using heart valve bracket as description made by implant, it will be appreciated by those skilled in the art thatBe that transportation system disclosed by the invention can also be placed to body using other implants as carrier in addition to heart valve bracketCorresponding position.Various changes and modifications can be made to the invention by those skilled in the art without departing from spirit of the inventionAnd range.These obvious modification and variations should belong to the present invention claims protection scope protection in.In addition, although this specificationIn use some specific terms, these terms are merely for convenience of description, does not constitute any special limit to the present inventionSystem.