CN207871027U - A kind of conveying device of the repeatable positioning of intervention heart valve - Google Patents

A kind of conveying device of the repeatable positioning of intervention heart valve Download PDF

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Publication number
CN207871027U
CN207871027U CN201820781988.3U CN201820781988U CN207871027U CN 207871027 U CN207871027 U CN 207871027U CN 201820781988 U CN201820781988 U CN 201820781988U CN 207871027 U CN207871027 U CN 207871027U
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CN
China
Prior art keywords
heart valve
outer sheath
engaging lug
gland
hollow
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn - After Issue
Application number
CN201820781988.3U
Other languages
Chinese (zh)
Inventor
王建安
张志飞
曾敏
吴世广
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Hangzhou Qiming Medical Devices Co ltd
Original Assignee
HANGZHOU QIMING MEDICAL DEVICE CO Ltd
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Publication date
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Publication of CN207871027U publication Critical patent/CN207871027U/en
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436Deployment by retracting a sheath
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466Delivery devices therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0061Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof swellable

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

The utility model discloses a kind of conveying device of the repeatable positioning of intervention heart valve, including core pipe, it is fixed with seeker and gland in core pipe, is intervention heart valve installation position between seeker and gland;The periphery for intervening heart valve installation position is equipped with axially slidable outer sheath, it is additionally provided with floating position-limiting item, the proximal end of the floating position-limiting item is the initiating terminal being fixedly installed relative to gland or core pipe, moves positive stop strip and floats between intervention heart valve installation position and outer sheath;The outer wall of the gland be equipped with for intervene the valvular matched positioning region of engaging lug, before the engaging lug is completely released out outer sheath, the floating position-limiting item is fettered the cooperation kept between engaging lug and positioning region by outer sheath;The outer sheath includes internal layer, middle layer and outer layer successively from inside to outside, and the middle layer includes first segment, second segment and third section successively by distal end to proximal end, and the first segment is engraved structure, and the engraved structure includes at least two hollow-out units.

Description

A kind of conveying device of the repeatable positioning of intervention heart valve
Technical field
The utility model is related to medical instruments fields, more specifically, the utility model is related to a kind of by heart valve prosthesis It is implanted to the conveying device of heart.
Background technology
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 valve Membrane damage is also increasing in China;In addition, congenital valve disease is also one of cardiopathic common disease factor.Considerable heart For 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 closed Infull patient etc. needs the interventional method treatment that new wound is small.It is in surgery cardiac valve replacement hand to intervene heart valve Develop under the inspiration of art, in recent years, percutaneous valve interventional procedure comes into being and sequential use takes with the mankind after 2000 Obtained 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 by conveying device after prosthetic heart valve holder compression, the valve of compression Holder usually has elasticity, applies prodigious power to compression tube when being in compressive state, these excessive power are difficult to make valve Holder 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 aorta Holder, valve bracket, efferent tract holder and engaging lug composition, when heart valve is compressed in conveying device, the engaging lug energy It is enough engaged in the holder fixation kit of conveying device, passes through the engaging of engaging lug and outer sheath during valve bracket discharges Collect complete valve bracket slow release.However, in the prior art engaging valve bracket engaging lug to collect power smaller, Valve bracket discharges the process later stage, and engaging lug is easily popped up from conveyor support fixation kit, and valve bracket is made to release completely It puts.At this point, if the problems such as finding deviations, just can not be recycled, can only pass through surgical replacement in time.
To overcome the valve bracket existing above problem, United States Patent (USP) US5683451 during implantation human body release public A kind of delivery apparatus and method of valve bracket control release are opened, the method by the way that track is arranged in conveying device is reduced Elastic dilatation frictional force caused by delivery conduit when conveying and discharging valve prosthesis, above-mentioned utility model reduce valve branch Friction between frame and delivery conduit.However, valve bracket during release due to elastic force is excessive suddenly discharge completely ask Topic can not still solve, and the valve bracket after release is in place cannot achieve the adjustment or secondary in place of position, so not only to operation When control accuracy requirement it is high, and there is also certain risks.
Moreover, the outer outer sheath of the valvular conveying of conveying intervention is currently used for mostly to be manufactured by high molecular material, Although the attribute performance of high molecular material is good, its elasticity and intensity are poor.Although reinforcement material is answered currently, also having and using For in high molecular material, such as woven network tube or elastic tube do and reinforce, by high molecular material coating reinforced pipe interior shape At outer outer sheath, still, above-mentioned measure only increases the fold resistance and pressure-bearing property of outer outer sheath, and apparent solution is outer When sheath withdraws intervention heart valve the intervention heart valve that encounters be difficult to recycle, outer sheath fold the problem of.
Utility model content
The utility model provides a kind of conveying device of the repeatable positioning of intervention heart valve, can be in intervention heart valve Fastening valve bracket finally discharges end during film release, prevents intervention heart valve before confirming release or need to further return Remove and pop out installation position during adjustment position of valve, at the same when intervening heart valve recycling outer sheath can provide it is stable Axial support and expansionary force to realize and stablize and are easy easy resetting intervention heart valve.
A kind of intervention heart valve repeats the conveying device of positioning, including core-pipe subassembly, is fixed with and draws on core-pipe subassembly Top guide and gland, wherein seeker are fixed on core-pipe subassembly distal end, and gland is extended in core-pipe subassembly proximal lateral, seeker and It is intervention heart valve installation position between gland;The periphery for intervening heart valve installation position is equipped with axially slidable epitheca Pipe,
It is additionally provided with floating position-limiting item, the proximal end of the floating position-limiting item is to be fixedly installed relative to gland or core-pipe subassembly Initiating terminal, floating position-limiting item float between intervention heart valve installation position and outer sheath;
The outer wall of the gland be equipped with for intervene the valvular matched positioning region of engaging lug, the connection Before 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 region It 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 end Include first segment, second segment and third section successively, the first segment is engraved structure, and the engraved structure includes at least two Hollow-out unit, distal end disconnected from each other setting of adjacent two hollow-out units in first segment circumferential direction.
In the utility model, floating position-limiting item be located at outer sheath and intervention heart valve between, effectively clog outer sheath with The diametrical gap of heart valve engaging lug is intervened, is reinforced, reinforcement outer sheath to the binding force of engaging lug, is reinforced radially Stabilization, the fastness that intervention heart valve engaging lug is connect with gland prevent the connection before the release completely of intervention heart valve Ear is detached from gland and is unable to control, and in the case where valve release is undesirable, and epitheca can be retracted again for intervention valve It is secondary in pipe to position or withdraw the pulling force that offer is strong, stablizes;Meanwhile outer sheath, by interior middle layer, not only enhancing is outer The axial support force of sheath, at the same can radial expansion drop promote valve radial contraction, reduce withdraw during resistance, i.e. a side Face ensures that the stabilization back pull to valve, on the other hand reduction valve has discharged the partially recycled resistance in outer sheath, effectively Securely achieve intervention heart valve conveying release and repeatable positioning.
Relative to intervention heart valve in the case that floating position-limiting item is not when valve loads or without outer sheath constraint Or the strength of materials that can freely swing or rely solely on itself for core-pipe subassembly keeps relative position and posture.
It is loaded into outer sheath in intervention heart valve to before being completely released out outer sheath, the floating position-limiting item is by outer Sheath constraint keeps the cooperation between engaging lug and positioning region;Outer sheath is withdrawn, during gradually discharging engaging lug, limit of floating Position item is also gradually released outer sheath, and when engaging lug discharges completely and is detached from gland, floating position-limiting item can freely be put Dynamic, the floating position-limiting item being released no longer applies engaging lug radial pressing force, that is, determines that intervention heart valve is good in place Afterwards, 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 time to even Infinite place acts on lug, 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 outer Fit tolerance between sheath and intervention heart valve engaging lug, filling outer sheath and intervention heart valve engaging lug are radially Gap, floating position-limiting item is simple in structure, to gap fill up will not increase valve implantation when transport system radial dimension;It is The reinforcing enhancing of cooperation is connected between existing intervention valve and gland, switching performance is more stablized;Floating position-limiting item is to connection The radial pressure of ear synchronizes disappearance with withdrawing for outer sheath, will not cause new interference to having discharged good valve.
In the present invention, heart valve is intervened in intervention heart valve installation position for installing intervention heart valve prosthesis The length of film installation position should be adapted with the length of intervention prosthetic heart valve holder, and intervention heart valve installation position includes not only Entire section between seeker and gland further includes the part that gland positioning region is extended to from gland distal end.
Preferably, the initiating terminal of the floating position-limiting item and at least one of the gland or the core-pipe subassembly It is mutually fixed.
The fixed position of floating position-limiting initiating terminal is close to gland, such as is in gland proximal end and (is leaned on along conveying device Proximal operator direction) tail portion or the core-pipe subassembly that is connected with the tail portion on, before surgery by outer sheath to intervening heart valve Film and floating position-limiting item are collected so that radially containing note leans against intervention heart valve periphery to floating position-limiting item, is intervening Heart 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 outside It sticks up.
In order to control the valvular axial position of intervention, match with gland intervening valvular proximal end and being typically provided T shapes, L-shaped, annular etc. generally may be used in the engaging lug of conjunction, engaging lug, and the positioning for receiving T shape, L shapes may be used in positioning region Slot, or it is caught in the plush copper etc. of annular, so that intervention heart valve rear axial position after valve loading is limited to positioning region, this practicality The prior art can be used for engaging lug shape itself in novel, be not the improved emphasis of the utility model.
Preferably, the positioning region is positioning plush copper, after valve loads, the engaging lug is set in positioning plush copper, Before the engaging lug is completely released out outer sheath, the floating position-limiting item is laminated on engaging lug to keep engaging lug and positioning Cooperation between portion.
Preferably, the positioning region is locating slot, engaging lug is inlaid in corresponding locating slot after valve loads, described Before engaging lug is completely released out outer sheath, the floating position-limiting item be laminated on engaging lug with keep engaging lug and positioning region it Between cooperation.
When for example, by using locating slot, when valve loads, engaging lug is caught in locating slot, to realize axially position, outer sheath After withdrawing, radially outward abjection locating slot of the engaging lug along holder.
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 ear Respective shapes can enhance locating effect.
Preferably, the floating position-limiting item is identical as locating slot quantity, and circumferential position corresponds.
Locating slot can guarantee that floating position-limiting item will not deviate during collecting with release.
Link closely locating slot and embedded company therein under outer sheath package at the proximal end position of floating position-limiting item after valve loads Lug.During outer sheath drops back release valve bracket, by floating position-limiting item in the extruding fastening effect of locating slot, prevent It the quick release of valve bracket and falls off.When valve bracket release process finds deviations, it can be pushed forward outer sheath, to The 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 ensured The 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 least Covering part engaging lug, to realize constraint to engaging lug radial motion, the end of floating position-limiting item can be on this basis Further extend towards distal end.
The end of the floating position-limiting item is for initiating terminal, and end also is understood as the distal end of floating position-limiting item Side.
Preferably, the distalmost end of the floating position-limiting item is aligned with gland distalmost end or is no more than gland distalmost end Or only slight beyond gland distalmost end.
When the floating position-limiting item has minimum length, floating position-limiting item can at least cover the engaging lug.In order into One step ensures compression effect, and the end of floating position-limiting item may be further extended to the distal side of gland or only slight beyond gland Distal 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 equal It 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 time The length of dynamic positive stop strip can wrap up entire valve bracket, and floating position-limiting item plays the role of sliding rail, ensure that outer sheath being capable of edge Sliding rail is pushed forward and withdraws and be not directly contacted with valve bracket.
Heart valve is intervened after valve loading, the floating position-limiting item is fettered by outer sheath engaging lug being limited in positioning In slot, epitheca inside pipe wall contacts with floating position-limiting item and provides radial constraint, and engaging lug can be blocked in fixed by floating position-limiting item In the slot of position, prevent from.
Preferably, the locating slot axially through, the floating position-limiting item at the position of locating slot cooperation, part or All 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 also Open, 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 part In the outside of radial opening, such as floating position-limiting section is T shapes, and locating slot is stretched into for stopping engaging lug in T shapes bottom end, and T Shape top dimension is limited to radial opening, therefore is in the outside of radial opening, can only ensure and epitheca inside pipe wall in this way Cooperation, 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 or Slightly wide, realization completely encloses radial opening, even if width is less than the width of radial opening, gap is at least unlikely to connect The width of the abjection of ear, floating position-limiting item is preferably identical as the radial opening axially through region, and can further prevent floating limits Position 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 slot There can be different matching relationships, in the case where outer sheath coats contact gland periphery, floating position-limiting item is stacked in connection The outer wall of ear, if the thickness of floating position-limiting item and engaging lug and the depth more than locating slot, floating position-limiting item are inside radially Push against engaging lug, on the contrary it is then contact, not will produce apparent binding force, but can ensure floating position-limiting item with to company The 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 deformation It still keeps limiting.
Preferably, after valve loading, the floating position-limiting item is contour or be higher than with the outer wall of gland radially The outer wall of gland.
Floating position-limiting item is not less than the outer wall of gland radially, can to avoid floating position-limiting item and epitheca inside pipe wall it Between 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 gland In portion.
Optionally, the floating position-limiting item extends at the position of engaging lug cooperation along straight line or curve.
When floating position-limiting two sides offset with locating slot corresponding side, floating position-limiting width can be appropriate when extending along curve Narrow, 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, the floating position-limiting item and wide at the position of engaging lug cooperation or not wide extension.
Optionally, the floating position-limiting item and uniform thickness or uniform thickness extension at the position of engaging lug cooperation.The floating limit The 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 to The 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 peripheral surface.
Floating position-limiting item radial development with the release of valve bracket during use, for the end for preventing after expansion Blood 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 prolonged Extend to the distal side flush with gland;An at least floating position-limiting end extends to the distal end of intervention heart valve installation position Side.
Preferably, the floating position-limiting item is isometric 3, and it 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 outer Diameter.
Preferably, the size of the floating position-limiting item is:Length 10mm-80mm, width 1-2mm, thickness 0.2- 0.5mm。
Preferably, the floating position-limiting strip adoption bonding, binding, lock, welding or integrated mode are fixed on institute On the component of connection.
Described floating position-limiting one end is initiating terminal, and the other end is end, and intermediate position is extended segment, the initiating terminal position Connecting portion in the tail portion of gland proximal end or tail portion and interior sheath, in a manner of bonding, binding, lock, welding or integration It is fixed on connected component.Floating position-limiting item extends along initiating terminal to distal end, in its natural state, the floating position-limiting item Initiating terminal is fixed, and extended segment and end axially unfold opening along core-pipe subassembly.
Optionally, after intervention heart valve loads, the floating position-limiting distal head is axially at least partly laminated on institute It states on engaging lug.
Optionally, engaging lug and gland are laminated in the floating position-limiting distal head axial direction.
Optionally, engaging lug and entire gland are laminated in the floating position-limiting distal head axial direction.
Optionally, the floating position-limiting distal head is more than gland distal end to intervening valvular diameter maximum portion Position.
Preferably, the position of the floating position-limiting item and outer sheath cooperation, and in the position of support assorted, at least Have 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 one side in (along conveying device far from the operator direction) tubular shell of outer sheath distal end Portion, axially extending arrangement of the fixed guide item along tubular shell.During outer sheath is collected with valve bracket is discharged, valve branch Frame is in direct contact with the fixed guide item in outer sheath tubular shell, is carried out by the smooth track that fixed guide item provides Quick, the control accurate of valve bracket.
Can be that contact portion or whole are fixedly linked, or use and be spaced apart between fixed guide item and epitheca inside pipe wall Multiple fixed points, since fixed guide item needs to move back and forth with outer sheath, preferably, the axial direction of fixed guide item Both 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 bracket In putting, fixed guide item provides smooth rail between outer sheath tubular shell and valve bracket (close to the one side of valve bracket) Road reduces contact friction, is 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 in the utility model, And the other end can at least be swung radially in the case of no external constraint, and due to the limitation of own material intensity, It is general also to 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 gland of each fixed guide item is staggered, also imply that with floating position-limiting item with it is solid Determine 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 interlocks Arrangement.
Preferably, the fixed guide item is circumferentially uniformly arranged 2,3 or 4.
Preferably, each fixed guide equal or different length.
Preferably, the fixed guide item is isometric 3, and it 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 outer Diameter.
Preferably, the size of the fixed guide item is:Length 10mm-80mm, width 1-2mm, thickness 0.2- 0.5mm。
Preferably, the length 60mm-80mm of the fixed guide item.
In the utility model, the floating position-limiting item, the shape of fixed guide item and size are arranged independently of each other, such as It can be the solid or hollow structure of strip;Its cross sectional shape is preferably flat, in order to reduce the whole radial direction in outer sheath distal end Size, the radial direction of thickness direction, that is, outer sheath of flat pattern.
For the ease of controlling the release and recycling of holder, the contact area with outer sheath is reduced, to reduce between the two Relative friction, floating position-limiting item, fixed guide item also have the selection of suitable size accordingly.
Preferably, the fixed guide strip adoption bonding, binding, lock, welding or integrated mode fix epitheca Inside pipe wall.
Preferably, the position of the fixed guide item and intervention heart valve cooperation has smooth surface and/or has Lubricant coating.
Preferably, the fixed guide item is polytetrafluoroethylene material.
In the utility model, the floating position-limiting item, fixed guide item material mutually independent can choose, as excellent Choosing is made of the preferable biocompatible materials of elasticity, and the prior art may be used in the selection of specific material.
To ensure that floating position-limiting item, fixed guide item have the dynamic friction factor of suitable elasticity and minimum, it is preferable that sliding Polytetrafluoroethylene (PTFE) (PTFE) can be selected in rail material.After valve bracket discharges in human body, sliding rail is dropped back with transport system, after sliding rail Friction is contacted with the valve bracket discharged completely during removing, the bullet during dropping back for anti-anti-slip track between valve bracket Power will not move holder, 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 surface Hydrophilic monomer or high molecular polymer with lubrication property, such as N, N- diformazans can be selected in lubricant coating, lubricating coating materials Base 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 successively Be 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 outer The 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 suitable It answers the internal layer and outer layer and expands, while to make the distal end of the outer sheath that there is better scalability, have foot Enough axially and radially support forces, and hollow-out unit is in rounding state, to further provide for enough axial directions and diameter To support force.So that in intervening heart valve removal process, enough axially and radially support forces are provided, so as to be given an account of Enter that heart valve is quick, safely recycles.
Two adjacent hollow-out units are set between the distal end of 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 first segment circumferential direction in one of the embodiments, Phase separation is interconnected or independent mutually in the proximal end of first segment circumferential direction, and is 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 institute It 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 segment Equipped at least one hollow hole.
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, The distal end protrusion setting of the hollow-out unit.
The radius of the arc section is 0.3mm-16mm in one of the embodiments,.
The utility model also provides a kind of epitheca, including delivery conduit, coupling tube and outer sheath, the delivery conduit, The coupling tube and the outer sheath are sequentially connected from the outer sheath distal to proximal end, the axis of the delivery conduit, described Coupling tube axis and the outer sheath axis overlap setting.
The utility model also provides a kind of intervention heart valve conveying device, for conveying intervention heart valve, including core Tube assembly, epitheca, operation handle, the core-pipe subassembly are connect with the operation handle, and the epitheca is slidably set in described On core-pipe subassembly, the intervention heart valve is loaded on the core-pipe subassembly, and is housed in the outer sheath of the epitheca.
Compared with prior art, the outer sheath, the epitheca with the outer sheath and intervention heart valve conveying dress The circumferential direction set 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 complied with described Internal layer and outer layer and expand, to make the outer sheath distal end have better scalability while, have enough axis To and radial support power, and hollow-out unit is in rounding state, to further provide for enough axially and radially supports Power.So that in intervening heart valve removal process, enough axially and radially support forces are provided, so that the intervention heart Valve is quick, safely recycles.Outer sheath is reduced using floating position-limiting item to a certain extent and intervenes valvular connect Contacting surface is accumulated, and smooth track is also used as, and is reduced relative friction forces when contacting two-by-two, can be led to during outer sheath is pushed forward and is withdrawn Cross with the contact of floating position-limiting item reduce doctor operation when direct active force, to realize to valve bracket discharge with recycle It accurately controls.Fixed guide item further is can be combined with, operation consent outer sheath collects valve bracket, fixed guide item and valve Membrane support is close to.In subsequent valve bracket release, fixed guide item carries between outer sheath tubular shell and valve bracket For smooth track, contact friction is reduced, the release and control of valve bracket are convenient for.
Description of the drawings
Fig. 1 is the structural schematic diagram of the utility model conveying device;
Fig. 2 is the structural schematic diagram at the utility model delivery device distal position;
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 are intervention heart valve part release conditions figure;
Fig. 5 b are the state diagram for intervening floating position-limiting item in heart valve release procedure division release;
Fig. 5 c are the state diagram intervened when heart valve discharges completely;
A kind of structural schematic diagram when Fig. 6 is using positive stop strip;
Fig. 7 a are the structural schematic diagram before another intervention apparatus release;
Fig. 7 b are the structural schematic diagram (opposite Fig. 7 a, eliminate part outer sheath) before the release of Fig. 7 a intervention apparatus;
Fig. 8 is structural schematic diagram when being also equipped with fixed guide;
Fig. 9 is outer sheath schematic cross-section;
Figure 10 a are the preceding state diagram of intervention apparatus release completely when being equipped with floating position-limiting item and fixed guide;
Figure 10 b are that the preceding state diagram of intervention apparatus release completely when being equipped with floating position-limiting item and fixed guide is (opposite Figure 10 a eliminate part outer sheath);
Figure 11 a are the schematic diagram that engaging lug matches position with gland;
Figure 11 b are the engaging lug of Figure 11 a by the schematic diagram after being pressed on floating position-limiting item;
Figure 12 a are the schematic diagram that another engaging lug matches position with gland;
Figure 12 b~Figure 12 d are 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 are 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 utility model;
Figure 15 is the structural schematic diagram at delivery device distal position provided by the utility model;
Figure 16 is the structural schematic diagram of outer sheath provided by the utility model;
Figure 17 is the schematic cross-section of delivery conduit provided by the utility model;
Figure 18 is intervention heart valve structural schematic diagram provided by the utility model;
Figure 19 is the schematic cross-section of outer sheath provided by the utility model;
Figure 20 is the structural schematic diagram of the second middle layer provided by the utility model;
Figure 21 is the structural schematic diagram at another visual angle of the second middle layer provided by the utility model;
Figure 22 is the flaring state structural schematic diagram of the structure of the second middle layer provided by the utility model;
Figure 23 is the second middle layer distal structure schematic diagram provided by the utility model;
Figure 24 is the schematic enlarged-scale view at E in Figure 21 provided by the utility model;
Figure 25 is the schematic enlarged-scale view at F in Figure 22 provided by the utility model;
Figure 26 provides the second middle layer distal end another example structure schematic diagram for the utility model.
Specific implementation mode
The utility model is described in detail below in conjunction with drawings and examples.It should be appreciated that described herein Specific embodiment only to explain the utility model, is not used to limit the utility model.Proximal end described in text refers to along conveying It is along the one end of conveying device far from operator direction, embodiment intermediary that device, which leans on the one end in proximal operator direction, the distal end, Enter heart valve by taking valve bracket as an example.
Referring to Fig. 1, the utility model conveying device include seeker 2, core-pipe subassembly 7, floating position-limiting item 1, gland 3, Interior sheath 4, outer sheath 5 and operation handle 6.
Seeker 2 and gland 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 gland 3, is intervention heart valve installation position between seeker 2 and gland 3;Epitheca Pipe 5 is in the periphery of intervention heart valve installation position and can slide axially, the proximal end of core-pipe subassembly 7 and outer sheath 5 with operation Handle 6 is connected, and the sliding axially relative to core-pipe subassembly 7 of outer sheath 5 can be realized by operation handle 6, in addition interior sheath 4 It according to needing to be arranged, can also omit, interior sheath 4 is sleeved on core-pipe subassembly 7 and is located at 3 proximal lateral of gland, and interior sheath 4 is general It is not axially moved with outer sheath 5, when core-pipe subassembly is made of stainless steel, interior sheath is it is also assumed that be overlay film in core pipe The coating layer of 7 outer surface of component.
Core-pipe subassembly 7 can also be to be linked to be by two sections of plugged and fixeds, plugging position is preferably placed at fixation with single part To ensure the smooth of bonding strength and appearance in first 3.
Floating position-limiting item 1 is isometric three in Fig. 1, is arranged successively in the circumferential, the case where no outer sheath 5 fetters It is stretched naturally in release conditions down.
Referring to Fig. 2, the different parts of floating position-limiting item 1 can be divided into initiating terminal 103,102 and of extended segment according to present position End 101, initiating terminal 103 are fixed on core-pipe subassembly 7 and are in the proximal lateral of fixed head-tail 32, visible in figure to be located at interior sheath Between pipe 4 and fixed head-tail 32.Initiating terminal 103 can certainly be arranged on core-pipe subassembly 7, for example be arranged in fixation On core-pipe subassembly 7 between the proximal lateral of head-tail 32 and the distal side of interior sheath 4.The periphery of gland 3 is equipped with locating slot, by It is needed in locating slot and intervenes valvular engaging lug cooperation, therefore its position and shape can match with engaging lug, In figure locating slot there are three and axial position interlaced arrangement, such as the locating slot 31 in figure and locating slot 33, in order not to as resistance The extension of floating position-limiting item 1 is kept off, locating slot is used axially through structure, and it is fixed radially to extend out disengaging for engaging lug when valve bracket discharges Position slot, therefore locating slot radial outside is open, that is, has radial opening.
Locating slot is axially through alar part of the both sides with extension, to coordinate the engaging lug of T shapes, floating position-limiting item 1 in figure By corresponding locating slot axially through position when extending to distal end, the floating position-limiting item 1 in Fig. 2 is in loading condition.
Bonding can be used in the initiating terminal 103 of floating position-limiting item, binding, lock, welding, integrated mode are fixed.It is viscous Condensation 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 be latched made of alloy material, then pass through lock Banding initiating terminal is detained, for example, see Fig. 3,103 banding of initiating terminal 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 gland 3 or core-pipe subassembly 7.
Floating position-limiting item 1 is the solid or hollow structure of strip, and solid flat bar, end 101 are used in the present embodiment In order to avoid the outer rim structure of arc can be used in corner angle (referring to Fig. 4).
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 most When 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 ensure that there is floating position-limiting item 1 smaller dynamic friction factor, floating position-limiting item 1 to select Polytetrafluoroethylene material is fabricated;Every 1 long 15mm of floating position-limiting item in figure, the positioning well width phase of width and gland 3 It 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 position Locating slot and further extend towards distal end, valve bracket 8 is with there are three the engaging lugs 81 of T shapes, in order to adapt to engaging lug shape, Locating slot on the basis of T shapes axially through, that is, be in crosswise, in order to ensure limit effect, locating slot axially through region It 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 perforation Region 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 ensure Locating slot is partially or completely sunk to, the outside of floating position-limiting item 1 can be slightly higher than the peripheral surface of gland 3, to reduce gland 3 Friction between 5 inner wall of peripheral surface and outer sheath.
When valve bracket 8 is loaded into conveying device, floating position-limiting item 1 is wrapped in valve bracket 8 and is collected together in outer In sheath 5;During valve bracket 8 discharges, as shown in Figure 5 a, along the directions arrow M, outer sheath 5 is along floating position-limiting Item 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 time State:When holder engaging lug 81 is in outer sheath 5, due to the constraint of outer sheath 5, floating position-limiting item 1 acts on holder engaging lug On 81, the pop-up of holder engaging lug 81 is prevented.Then, as shown in Fig. 5 b, as outer sheath 5 is returned further along arrow M It removes, the end 101 of floating position-limiting item 1 is detached from the constraint of outer sheath 5, and extended segment 102 and holder engaging lug are still in outer sheath 5 Interior, extended segment 102 acts on holder engaging lug 81 at this time, gives 81 1 radial pressures of engaging lug of valve bracket, makes The engaging lug for obtaining valve bracket is clenched, and is overcome holder and is discharged the huge expansive force generated in the process, jail in self-expanding Admittedly being fastened in the locating slot 33 of bracket fixing head 3, and it is avoided to be detached from the risk that the positioning region of gland discharges completely.At this time If it was found that valve releasing position is inaccurate, the outer sheath 5 that moves ahead can be passed through so that valve bracket 8 is retracted outer sheath 5 again It is interior, carry out recycling and secondary release.The utility model compared with the prior art, can fast implement recycling and positioning, a side herein Face is the axial support force for having enhancing due to outer sheath 5 (structure about outer sheath 5 is seen description below), can radial expansion Drop promotes the radial contraction of valve bracket, secondly as floating position-limiting item 1 plays the role of gasket, can be greatly lowered outer Resistance when sheath forward slip so that outer sheath 5, which quickly moves ahead, compresses valve bracket.
Finally, it when the current releasing position of determination is accurate, as shown in Figure 5 c, continues on arrow M and withdraws outer sheath 5, The end 101 and extended segment 102 of floating position-limiting item 1 end 101 of floating position-limiting item 1 and are prolonged no longer by the constraint of outer sheath 5 It stretches section 102 with the expansion of valve bracket 8 to be unfolded, floating position-limiting item 1 is in off working state at this time, i.e., does not apply force to On engaging lug 81, to complete the release of valve bracket 8, completely release when, floating position-limiting item to the radial pressure of engaging lug with Outer sheath 5 withdraws and synchronizes disappearance, will not cause new interference to having discharged good valve bracket, can effectively prevent valve The displacement of holder.
The active force that floating position-limiting item 1 applies holder engaging lug, the on the one hand constraint from outer sheath, in an other side Face, the initiating terminal 103 of floating position-limiting item 1 are fixed due to abutting gland 3, and the extended segment 102 of neighbouring initiating terminal 101 is by rising The binding force at beginning 103, when the engaging lug of valve bracket 8 is embedded into the locating slot 33 of gland 3, floating position-limiting item 1 is close Locating slot 33 is close in end extended segment, gives one radially inward pressure of engaging lug of valve bracket 8, can prevent valve bracket 8 The premature locating slot 33 for being detached from gland 3 of engaging lug during release and cause valve bracket 8 to discharge suddenly, while in valve During membrane support 8 discharges, if the problems such as finding deviations needs to place again, since 1 proximal end of floating position-limiting item is given The binding force of engaging lug in locating slot 33, it is ensured that outer sheath 5 is pushed forward along floating position-limiting item 1, to the part valve discharged Holder 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 gland are neat It 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 gland 3 Smooth 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 floating The contact of positive stop strip 1 reduces direct active force when doctor operates, to realize the accurate control discharged to valve bracket 8 with recycling System.
Floating position-limiting item 1 is three solid strips in Fig. 6, and is made of polytetrafluoroethylene material, floating position-limiting item 1 Initiating terminal is fixed on the proximal end tail portion of gland 3 by bonding mode, and the end and 3 distal end of gland of floating position-limiting item 1 are neat It is flat, i.e., engaging lug position can be at least completely covered and be limited in locating slot, 1 width of floating position-limiting item is axial with locating slot 33 Penetrate through the equivalent width in region, thickness 0.5mm.
The structural schematic diagram before valve bracket release completely is shown in conjunction with Fig. 7 a, 7b, Fig. 7 a, in fig.7b, in order to clear Chu 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 item 1 and gland 3 outside part outer sheath 5.In the present embodiment, valve bracket 8 has engaging lug 81, when valve bracket 8 fills When being downloaded in conveying device, the length that floating position-limiting item 1 extends is suitable with 3 remote location of gland, and end is only capable of compressing embedding Enter the engaging lug inside gland locating slot 33.When valve bracket 8 is transported to human body and discharges, outer sheath 5 is dropped back, valve branch Frame 8 gradually discharges.At this point, the engaging lug 81 of valve bracket 8 is embedded into the locating slot 33 of gland, engaging lug is limited by floating The force effect that collects of position 1 initiating terminal of item is firmly strapped in locating slot 33, avoids having discharged valve bracket 8 to the application of engaging lug end Extend out power and make the premature complete release of holder.
Using the floating position-limiting item 1 of shorter size, the influence normally discharged to holder and unnecessary constraint are can avoid, is floated The length of dynamic positive stop strip 1 can also extend to the axial central region of valve bracket 8, such as valve when being discharged completely no more than valve Point 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, gland 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, and It is fixed on 5 distal tubular shell inner surface of outer sheath, smooth track is provided between valve bracket 8 and outer sheath 5.
The circumferential position of each fixed guide item 51 and the locating slot in gland 3 (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 gland 3, and position and locating slot are one by one Staggeredly.
Fixed guide item 51 is solid flat bar, length 10mm-80mm, width 1-2mm, thickness 0.2-0.5mm, this implementation The length about 60mm corresponding to 8 axial length of valve bracket of fixed guide item 51 in example.
Fixed guide item 51 fixes 5 inner wall of outer sheath using bonding, binding, lock, welding or integrated mode, fixed Gib block 51 is polytetrafluoroethylene material, and the position coordinated with intervention heart valve 8 is applied with smooth surface and/or with lubrication Layer.Under best realization method, fixed guide item 51 and the inner wall of outer sheath 5 are integrally formed, and fixed guide item 51 is to epitheca The projecting inward fin of pipe 5, with smooth surface and/or with lubricant coating.
In conjunction with Figure 10 a, 10b, Figure 10 a show that intervention apparatus when being equipped with floating position-limiting item and fixed guide discharges State diagram is omitted 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 1 The part outer sheath 5 being located at outside floating position-limiting item 1 and gland 3.When valve bracket 8 discharges, outer sheath 5 passes through fixation Gib block 51 and 8 contact slide of valve bracket can withdraw outer sheath 5 in the case of frictional force very little and realize gradually releasing for holder It puts.
When outer sheath 5 withdraws the position of gland 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 5 On.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, valve The 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 released It puts.
As a further improvement of the utility model, in other embodiments, the floating position-limiting item part setting On/within the locating slot of gland, plays limit bracket fixed ear and radially extend out disengaging locating slot, another part is arranged in fixation On head periphery wall, play the role of sliding rail, outer sheath is slided along this floating position-limiting item.It is corresponding with locating slot under best mode Floating position-limiting distalmost end and gland alignment or no more than gland distalmost end or only slight beyond gland distalmost end.
Following embodiment is mainly for the length and shape and engaging lug of floating position-limiting item and the cooperation of gland Mode is described further, and related other component may be used or in conjunction at least one of aforementioned each embodiment.
Referring to Figure 11 a and Figure 11 b, engaging lug 81 is T shapes, and the positioning region in gland 3 is locating slot 33, and valve loads Afterwards, engaging lug 81 is inlaid in the corresponding locating slot of shape 33, and floating position-limiting item 1 is laminated on engaging lug 81 by the constraint of outer sheath On, to prevent engaging lug 81 from deviating from from locating slot 33, during holder is released, when outer sheath completely disengages floating position-limiting item 1 When, just release the limit of engaging lug 81.
Referring to Figure 12 a~Figure 12 d, engaging lug 81 is U-shaped, and U-shaped opening side is connected with holder, and U-shaped opening is closed, Positioning region in gland 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 axial Positioning, in order to avoid the excessively diameter convex of engaging lug 81 is equipped with sedimentation in the outer wall of periphery, that is, gland 3 of positioning plush copper 34 Slot 35, engaging lug 81 are stacked in subsider 35, can be realized with the outer wall of gland 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 gland 3, point Fork 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 to Outside.
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 gland 3 Outside, 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 gland, fixed For 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 81 On.
The distal side of the visible floating position-limiting items of Figure 13 a 1 is laminated on engaging lug 81, and the distal side of floating position-limiting item 1 is not yet Positioning 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 items of Figure 13 b 1 is laminated on engaging lug 81, and the distal side of floating position-limiting item 1 is in axis The positioning region being upwardly into major general's gland is completely covered, that is, has crossed positioning plush copper 34, reaches the distal side of gland 3, Axis laminates engaging lug 81 and entire gland 3 up towards distal end side.
The distal side of the visible floating position-limiting items of Figure 13 c 1 is laminated on engaging lug 81, and the distal side of floating position-limiting item 1 is in axis Up over gland.
The distal side of the visible floating position-limiting items of Figure 13 d 1 is laminated on engaging lug 81, and the distal side of floating position-limiting item 1 is in axis It up over gland, reaches and intervenes the maximum position of heart valve diameter, due to being fettered by outer sheath after valve loading, be situated between It is almost the same to enter valvular outer diameter, therefore the maximum position of diameter can be regarded as the maximum position of diameter under release conditions.
Following embodiment is illustrated mainly for the improvement of outer sheath, and related floating position-limiting item or other component can To be employed or in combination at least one of aforementioned each embodiment.
Referring to Figure 14 and Figure 18, conveying device 100 intervenes heart valve 82 to the corresponding position of human body to convey.Institute The intervention heart valve 82 stated can be valve bracket or the holder of its type.
The conveying device 100 include core-pipe subassembly 10, epitheca 20, operation handle 30, the core-pipe subassembly 10 with it is described Operation handle 30 connects, and the epitheca 20 is slidably sheathed on the core-pipe subassembly 10, and the epitheca 20 is located at the core pipe group Between part 10 and the operation handle 30.The intervention heart valve 82 is loaded on the core-pipe subassembly 10, and is housed in institute It states in epitheca 20.To control, the relatively described epitheca 20 of the core-pipe subassembly 10 is axial to move ahead or returns the operation handle 30 It removes, so that the intervention heart valve 82 release or recycling.
The core-pipe subassembly 10 includes core pipe 11, seeker 12.The proximal end of the core pipe 11 connects with the operation handle 30 It connects, the distal end of the core pipe 11 is pierced by from the epitheca 20 and is connect with the seeker 12.Herein, it is to be understood that The proximal end is that in contrast, specifically, the proximal end refers to leaning on proximal operator side along the conveying device 100 with the distal end To one end, the distal end be along the one end of the 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 behaviour Make the connection of handle 30, the distal end of the middle pipe 111 is equipped with gland 1111 and floating position-limiting item 1112.The gland 1111 are fixed for the intervention heart valve 82 matching with that will intervene heart valve 82.The loading section 112 is located at described solid Determine between first 1111 and the seeker 12, the proximal end for loading section 112 is retained in the gland 1111, the loading The distal end of section 112 is connect with the seeker 12, and the loading section 112 is located in the epitheca 20, and the loading section 112 is used In loading the intervention heart valve 82.
Further, the floating position-limiting item is more than the gland 1111 described in the axial length of the core pipe 11 The 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 pipe On 111.The floating position-limiting item 1112 reduces epitheca 20 and intervenes the contact area of heart valve 82 to a certain extent, As smooth track, reduces epitheca 20 and intervene relative friction forces when heart valve 82 contacts, it is relatively described outer in core pipe 11 Sheath 20 can reduce direct work when doctor's operation by the contact with floating position-limiting item 1112 during axially moving ahead or withdraw Firmly, the intervention release of heart valve 82 is accurately controlled with recycling to realize.
Referring to Figure 16, epitheca 20 is usually formed as tubular structure, epitheca 20 have certain flexibility, axial support force with And radial support power.Including delivery conduit 21, coupling tube 22 and outer sheath 23, the proximal end of the delivery conduit 21 with it is described Operation handle 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 with The inside connection setting of the outer sheath 23.The coupling tube 22 is equipped between the delivery conduit 21 and the outer sheath 23, It is interconnected by the coupling tube 22 between the delivery conduit 21 and the outer sheath 23.The core pipe 11 sequentially passes through The delivery conduit 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 the 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 21 Different implantation points can be met.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 defeated Send 21 radial direction of conduit that the first internal layer 211, the first middle layer 212 and the first outer layer 213 are set from the inside to the outside successively.It is described A variety of combinations may 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 212 Connection;Or first internal layer 211, first outer layer 213 are realized and the first middle layer by immersion liquid or sprayed coating mode 212 connection.The profit of identical or different high molecular material may be used in first internal layer, 211 and first outer layer 213 Sliding elastomer so that the delivery conduit 21 have it is certain it is flexible simultaneously, but also with enough axial support forces, also have Standby sliding capability.To even if during implantation intervenes heart valve 82, have tortuous implantation site (for example, working as edge When moving body arch of aorta bending) it can also complete accurately to be implanted into.PTFE can be used in first internal layer 211 (Polytetrafluoroethylene, polytetrafluoroethylene (PTFE)), PEBAX (Polyeherblock amide, polyether block amide) Equal high molecular materials, first outer layer 213 is using PTFE, PU (Polyurethane, polyurethanes, referred to as poly- ammonia Ester), Pebax (A Kema nylon elastomers), the materials such as PE (polyethylene).In the present embodiment, first internal layer 211 with And first outer layer 213 is using the lubrication elastomer of identical high molecular material, including PTFE (Polytetrafluoroethylene, polytetrafluoroethylene (PTFE)) or PEBAX (Polyeherblock amide, polyether block acyl Amine).
First middle layer 212 is formed using metal braid or by cuts in metallic pipe, to make the delivery conduit 21 can keep certain axial support force again with centainly flexible.Preferably, first middle layer 212 is adopted It is formed with cuts in metallic pipe.
Coupling tube 22 is used to connect the transition between the delivery conduit 21 and the outer sheath 23.Further, institute The 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 accommodate State intervention apparatus 82.Before discharging the intervention apparatus 82, the intervention apparatus 82 is stored in mixture of ice and water by compression In the outer sheath 23.Herein, it is to be understood that referring to Figure 18, the intervention apparatus 82 includes holder 83 and valve Film, the valve is by manually sewing on the holder 83.The holder 83 uses nick-eltitanium alloy stent, the valve to use The biomaterials such as Pigs Hearts packet, bovine pericardium make.The nick-eltitanium alloy stent has shape memory function, becomes in mixture of ice and water Soft, to be easily folded in the outer sheath 23 by compression, when discharging in blood, expansion restores shape when its expansion.
During release, by operating operation handle 30 so that the outer sheath 23 is axially moved with respect to core pipe 11, is released Intervention apparatus 82 is put, during this, once find the releasing position of the intervention apparatus 82 not just, by operation 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 apparatus 82, in outer sheath 23 Under binding force (adjacent circumferential expansion resistance) effect, so that the intervention apparatus 82 is compressed 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 22 Close setting.The outer sheath 23 includes three-decker.Specifically, the outer sheath 23 includes along 23 radial direction of the outer sheath Second internal layer 23a, the second middle layer 23b and the second outer layer 23c are set from the inside to the outside successively.It is the second internal layer 23a, described A variety of combinations may be used between second middle layer 23b and the second outer layer 23c.For example, the second internal layer 23a And it is connected by heat fusing or binder mode between the second outer layer 23c and the second middle layer 23b.Described second The lubrication elastomer of identical or different high molecular material may be used in internal layer 23a and the second outer layer 23c, so that described outer Sheath 23 have it is certain it is flexible simultaneously, but also with enough axial support forces, be also equipped with sliding capability.In described second PTFE (Polytetrafluoroethylene, polytetrafluoroethylene (PTFE)) high molecular material, the second outer layer 23c may be used in layer 23a It may be used using PTFE, PU (Polyurethane, polyurethanes, abbreviation polyurethane), Pebax (A Kema nylon bullets Property body), the materials such as PE (polyethylene).In the present embodiment, the second internal layer 23a and the second outer layer 23c is to use The lubrication elastomer of identical high molecular material, including PTFE (Polytetrafluoroethylene, polytetrafluoroethylene (PTFE)).
Referring to Figure 20 and Figure 21, the second middle layer 23b is enhancement layer, and stainless steel tube or Nitinol pipe can be used It cuts, also Nitinol pipe, rest part can be used to use stainless steel tube in first segment.The second middle layer 23b is used To improve the axial support force, radial support power, binding force (adjacent circumferential expansion resistance) and the flexibility that include the outer sheath 23 Deng in during the withdrawing of heart valve 82 of intervention, providing enough binding forces and compress the intervention heart valve 82 In receiving to outer sheath 23.Secondly, the axial support force and flexibility that the second middle layer 23b is provided can make the outer sheath 23 With 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 first Section 231, the second segment 232 and the third section 233 are sequentially connected, and the first segment 231 is close to the outer sheath 23 Distal 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 segment 231 and third section 233 centre.
Referring to Figure 20-Figure 25, the first segment 231 is using including engraved structure, so that the distal end tool of the outer sheath 23 Prepare enough 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 engrave The 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 231 are circumferentially arranged setting, and adjacent two hollow-out units 2311 divide mutually in the circumferential distal end of the first segment 231 From.It can understand, there are hollow out gap L, institutes between the circumferential direction of first segment 231 between the adjacent hollow-out unit 2311 The range of hollow out gap L is stated between 0.5mm-8mm.And since the first segment 231 is in the second internal layer 23a and Between two outer layer 23c, first segment 231 can comply with the second internal layer 23a and the second outer layer 23c and expand, because of nickel after expansion Second middle layer 23b of titanium alloy tube has shape memory function and promotes to reset, to considerably increase 23 distal end of outer sheath Radial support power toughness;Meanwhile the hollow-out parts of engraved structure are in rounding state, to provide enough axial supports The occurrence of power is effectively prevented when withdrawing the intervention heart valve 82,23 distal end fold of the outer sheath;Its Secondary, circumferential hollow-out unit 2311 disconnected from each other makes 23 distal end of the outer sheath have the flaring to the outer sheath adjacent circumferential expansion, To when recycle intervention heart valve 82 with cushioning effect so that the release for intervening heart valve 82 with And recycling 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 exists The 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 231 Cloth.Axial direction and circumferential not closed diamond shape, the rectangle etc. of distal end are formed between two adjacent hollow-out units 2311 Space.
Referring to Figure 26, in other embodiments, the hollow-out unit 2311 in the circumferential direction of the first segment 231 is adjacent Two hollow-out units 2311 between can form one group of hollow-out unit 2311.And between two groups of adjacent hollow-out units 2311 In the setting disconnected from each other of the circumferential direction of first segment 231.It is, of course, also possible to be formed between 3 hollow-out units 2311 arranged successively One group of 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.
Two adjacent hollow-out units 2311 are disconnected from each other in the circumferential distal end of the first segment 231.Adjacent Two hollow-out units 2311 are while the circumferential proximal end of the first segment 231 can interconnect or part connects It is connect with the second segment 232.
In other embodiments, two adjacent hollow-out units 2311 are in the circumferential close of the first segment 231 End is independently arranged mutually, and is connect respectively with the second segment 232, i.e.,:It is appreciated that in the present embodiment, adjacent two It 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 out Unit 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 holes It interconnects or is not connected between 2311b, that is, setting is spaced between two adjacent hollow hole 2311b, described with reinforcement 2311 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 holes 2311b arranges along the axial of the hollow-out unit 2311 from distal end to proximal end;Or, two hollow hole 2311b are along institute State being circumferentially arranged for hollow-out unit 2311.In other embodiments, hollow hole there are three being opened up in the hollow-out unit 2311 2311b, three hollow hole 2311b can be in linear type, and the arrangement modes such as triangular shape are arranged in the hollow-out unit 2311 On.It is to be appreciated that the purpose that the arrangement mode of hollow hole 2311b and fabric hollow hole 2311b is arranged is intended to described in raising The overall construction intensity and flexibility of outer sheath, radial direction and axial support force.As long as and the outer sheath can be improved The arrangement of overall construction intensity can be carried out arranging in the present invention, therefore to hollow hole 2311b in utility model Arrangement mode be not just restricted.
The hollow-out unit 2311 includes at least one hollow out segment 2311a.Offered on the hollow out segment 2311a to A few hollow hole 2311b.Adjacent hollow-out unit 2311 is divided mutually between the hollow out segment 2311a of its distalmost end From.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 unit The 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 engrave 60%-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, institute It states and is heated between the second middle layer 23b, the second outer layer 23c when combining so that the second middle layer 23b and described the The binding force bigger that adherence quality between two internal layer 23a and the second outer layer 23c more preferably, between three layers combines, associativity It is more preferable, further, improve axial support force, the radial support power of outer sheath 23, and it is enough so that the outer sheath is had Flexibility;Secondly, the area that hollow hole 2311b areas account for hollow-out unit 2311 is sufficiently large, is conducive in heating cohesive process In hollow hole 2311b gas discharge, further increase the second internal layer 23a, the second middle layer 23b, the second outer layer 23c it Between binding force, to enhance the overall construction intensity of the outer sheath 23.
The hollow hole 2311b is substantially in " drops ".When being set in the hollow-out unit 2311, there are two hollow holes Substantially it is in the figure of eight structure when 2311b, described in two.
Referring to Figure 20 and Figure 23, the distal end of the hollow-out unit 2311 is additionally provided with arc section 2311a1.The arc section 2311a1Arc to the distal end of the hollow-out unit 2311 protrude be arranged.The arc section 2311a1With the hollow-out unit 2311 surround the hollow hole 2311b.Arc section 2311a1With inner circle segmental arc and outer circle segmental arc, the half of the inner circle segmental arc Diameter ranging from 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 arc Ranging from 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 uses arc section 2311a1Design not only effectively prevent intervention heart valve 82 return During removing, situations such as intervention heart valve 82 is punctured, torn by the distal end of first segment 231;Secondly, using arc section 2311a1The radial support power that bigger can be provided makes the distal radial support force bigger of the outer sheath 23, to given an account of Enter 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, adjacent two institutes can be not provided in the hollow-out unit 2311 State the distal end disconnected from each other setting circumferential in the first segment 231 of hollow-out unit 2311.
The second segment 232 is to including the overall construction intensity and flexibility that improve the offer of outer sheath 23.Institute The 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 carry For the binding force of bigger, 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 first Changeover portion 2321, the bending section 2322 and second changeover portion 2323 are from the distal end of second middle layer 22 to close End is sequentially distributed.Second segment 232 between the First Transition section 2321 and the first segment 231 by connecting.First mistake It crosses in section 2321 and offers multiple connecting hole 2321a.The gross area of the connecting hole 2321a accounts for the First Transition section 2321 The 60-70% of area, to make to heat faying face when combining between second segment 232 and the second internal layer 21a, the second outer layer 23c Product maximizes, and while improving the overall construction intensity of outer sheath 23, so that the outer sheath 23 is had flexibility, and have enough Axially and radially support force.
Preferably, the connecting hole 2321a includes round connecting hole 2321a, oval connection hole 2321a, rectangular connection Hole 2321a etc..In the present embodiment mode, multiple round connecting hole 2321a are offered in the First Transition section 2321.It is more A circle 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 up Support 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 flexibility Discharge 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 described Bending section 2322 is formed by helical cut.Spacing between the adjacent spiral section 2322a is t1, the bending section 2322 That 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 bending The 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 23c Bonded area when conjunction maximizes, and to make the outer sheath 23 have flexibility, and has enough axially and radially branch Support force.
In other embodiments, the bending section 2322 can be C-shaped circle, and the bending section 2322 is cut by C shapes It is cut into C-shaped circle.It is spaced setting between two adjacent C-shaped circles, but does not turn off, i.e.,:Between two adjacent C-shaped circles mutually It is connected.It is contacted by reinforcing rib 2322a between the C-shaped circle.It further, can between the two neighboring C-shaped circle To be to be equally spaced, it may not be and be equally spaced, be not restricted in the present embodiment.
Second changeover portion 2323 is to the connection between the bending section 2322 and the third section 233.Described Multiple connecting hole 2321a are offered on two changeover portions 2323.Multiple connecting hole 2321a are set, to make the second changeover portion Bonded area when combining is heated between 2323 and the second internal layer 21a, the second outer layer 23c to maximize, further, Improve outer sheath 23 overall construction intensity while, so that the outer sheath 23 is had flexibility, but have enough axial directions and Radial support power.
Preferably, in the present embodiment, second changeover portion 2323 offers multiple square attaching apertures 2321a.It is more A 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, that The 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 polylith floating piece 2331, institute Being provided at circumferentially spaced in the third section 233 of polylith floating piece 2331 is stated, every piece of floating piece 2331 offers multiple companies Meet hole 2321a.Herein, the polylith floating piece 2331, which is provided at circumferentially spaced, is conducive to described collapse the third section 233 In the coupling tube 22, meanwhile, multiple connecting hole 2321a are set on floating piece 2331 so that third section 233 and described second Bonded area when combining is heated between internal layer 21a, the second outer layer 23c to maximize, and further, improves outer sheath 23 Overall construction intensity.
In the present invention, when being loaded due to the intervention heart valve 82 can be become to the cold by using Nitinol Soft characteristic is compressed, to intervene 82 compression loaded of heart valve described in mixture of ice and water in the outer sheath 23 It is interior.During the intervention heart valve 82 discharges in human body, intervention heart valve 82 is gradually from the outer sheath 23 It is unfolded distal end.It is envisioned that comparing and mixture of ice and water, the temperature of human body are the temperature of significantly larger than mixture of ice and water, releasing During putting, the intervention heart valve 82 is equivalent to be heated in human body, and the intervention heart valve 82 is described outer The expansionary force of the distal end of sheath 23 is very big.When finding the position inaccuracy of the intervention release of heart valve 82, it is desirable to will The intervention heart valve 82, which re-compresses, to be recycled in outer sheath 23, and the outer sheath 23 just needs sufficiently large axis to be offered To, radial support power 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 the institute of outer sheath 23 The associativity stated between the second internal layer 23a, the second middle layer 23b and the second outer layer 23c is more preferable, improves outer sheath 23 whole axial directions, radial support power, while making outer sheath that there is certain flexibility, to which the intervention heart valve 82 returns Sufficiently large axially and radially support force is provided during receipts.
Hollow hole 2311b specifically, by the distal end of the second middle layer 23b be arranged first segment 231, described first Circumferential direction of the hollow-out unit 2311 in 231 distal end of first segment in section 231 detaches from each other, to make the remote of the outer sheath 23 It holds scalability more preferable, enough axially and radially support forces is provided simultaneously with, further, from the hollow-out unit 2311 The 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 layer When heating combination between 23a, the second middle layer 23b, the second outer layer 23c, the second middle layer 23b made and institute State the binding force bigger of adherence quality more preferably, between three layers between the second internal layer 23a and the second outer layer 23c, associativity It is more preferable, and then improve the axial support force of the outer sheath 23, radial support power, and it is enough soft so that the outer sheath is had Toughness.
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 10 It 112 and is housed in epitheca 20.After intervention heart valve 82 is delivered to human lesion position, controlled by operation handle 30 10 opposite segments epitheca 20 of core-pipe subassembly moves ahead, so that intervention heart valve 82 is unfolded in the self-expanding of the epitheca 20.
When ensuring that 82 releasing position of intervention heart valve is accurate, core-pipe subassembly 10 continues to move ahead, and intervenes heart valve 82 Release is deployed in lesion locations, and intervention heart valve 82 is made to be detached from gland 1111, completes releasing for intervention heart valve 82 It puts.
If during release, it is found that the releasing position of intervention heart valve 82 is not right, core is controlled by operation handle 30 Tube assembly 10 is withdrawn, and epitheca 20 provides enough axially and radially support forces during withdrawing, and in the floating position-limiting The intervention heart valve 82 is compressed under the guiding of item 1112, intervention machinery 82 is housed in the epitheca 20, i.e., Complete the recycling of the intervention heart valve 82.
The utility model embodiment is using heart valve bracket to be described made by implant, and those skilled in the art can be with Understand to be conveying device disclosed by the utility model can also set in addition to heart valve bracket using other implants as carrier Enter the corresponding position to body.Those skilled in the art the utility model can be carried out various modification and variations without departing from The spirit and scope of the utility model.These obvious modification and variations should all belong to the protection domain protection of the requires of the utility model It is interior.In addition, although having used some specific terms in this specification, these terms are merely for convenience of description, not right The utility model constitutes any specifically limited.

Claims (15)

1. a kind of intervention heart valve repeats the conveying device of positioning, including core-pipe subassembly, guiding is fixed on core-pipe subassembly Head and gland, wherein seeker are fixed on core-pipe subassembly distal end, and gland is extended in core-pipe subassembly proximal lateral, seeker and solid Determine between head for intervention heart valve installation position;The periphery for intervening heart valve installation position is equipped with axially slidable outer sheath, It is characterized in that, being additionally provided with floating position-limiting item, the proximal end of the floating position-limiting item is to be set relative to gland or core-pipe subassembly fixation The initiating terminal set, floating position-limiting item float between intervention heart valve installation position and outer sheath;
The outer wall of the gland be equipped with for intervene the valvular matched positioning region of engaging lug, the engaging lug quilt Before releasing outer sheath completely, the floating position-limiting item is fettered by outer sheath keeps engaging lug and positioning region to be coordinated;
The outer sheath from inside to outside successively include internal layer, middle layer and outer layer, the middle layer by distal end to proximal end successively Including first segment, second segment and third section, the first segment is engraved structure, and the engraved structure includes at least two hollow outs Unit, distal end disconnected from each other setting of adjacent two hollow-out units in first segment circumferential direction.
2. the conveying device of the repeatable positioning of intervention heart valve as described in claim 1, which is characterized in that the floating limit At least one of the initiating terminal of position item and the gland or the core-pipe subassembly are mutually fixed.
3. the conveying device of the repeatable positioning of intervention heart valve as described in claim 1, which is characterized in that the positioning region To position plush copper, after the intervention heart valve loads, the engaging lug is set in positioning plush copper, and the engaging lug is complete Before releasing outer sheath, the floating position-limiting item is laminated on engaging lug to keep the cooperation between engaging lug and positioning region.
4. the conveying device of the repeatable positioning of intervention heart valve as described in claim 1, which is characterized in that the positioning region For locating slot, after the intervention heart valve loads, engaging lug is inlaid in corresponding locating slot, and the engaging lug is released completely Before releasing outer sheath, the floating position-limiting item is laminated on engaging lug to keep the cooperation between engaging lug and positioning region.
5. the conveying device of the repeatable positioning of intervention heart valve as described in claim 1, which is characterized in that intervention heart valve After film loads, the floating position-limiting distal head is axially at least laminated on engaging lug.
6. the conveying device of the repeatable positioning of intervention heart valve as described in claim 1, which is characterized in that the floating limit Engaging lug and gland are laminated in the distal head axial direction of position.
7. the conveying device of the repeatable positioning of intervention heart valve as described in claim 1, which is characterized in that the floating limit Engaging lug and entire gland are laminated in the distal head axial direction of position.
8. the conveying device of the repeatable positioning of intervention heart valve as described in claim 1, which is characterized in that the floating limit Position distal head is more than gland distal end to intervening valvular diameter maximum position.
9. the conveying device of the repeatable positioning of intervention heart valve as described in claim 1, which is characterized in that the floating limit Position item size be:Length 10mm-80mm, width 1-2mm, thickness 0.2-0.5mm.
10. the conveying device of the repeatable positioning of intervention heart valve as described in claim 1, which is characterized in that the floating Positive stop strip is with smooth surface and/or with lubricant coating.
11. the conveying device of the repeatable positioning of intervention heart valve according to claim 1, which is characterized in that adjacent Two hollow-out units are equipped with hollow out gap between the distal end of first segment circumferential direction, and the range of the hollow out gap L exists Between 0.5mm-8mm.
12. the conveying device of the repeatable positioning of intervention heart valve according to claim 1, which is characterized in that adjacent Two hollow-out units are disconnected from each other between the distal end of first segment circumferential direction, mutual in the proximal end of first segment circumferential direction Connection is independent mutually, and is connect with the second segment.
13. the conveying device of the repeatable positioning of intervention heart valve according to claim 1, which is characterized in that described to engrave Offer at least one hollow hole on dummy cell, the hollow hole is axial from distally proximally extending along the hollow-out unit.
14. the conveying device of the repeatable positioning of intervention heart valve according to claim 13, which is characterized in that described to engrave Emptying aperture area accounts for the 40%-80% of the hollow-out unit area.
15. the conveying device of the repeatable positioning of intervention heart valve according to claim 13, which is characterized in that described to engrave The distal end of dummy cell is equipped with arc section, the distal end protrusion setting of hollow-out unit described in the arcuate directions of the arc section.
CN201820781988.3U 2017-10-24 2018-05-24 A kind of conveying device of the repeatable positioning of intervention heart valve Withdrawn - After Issue CN207871027U (en)

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CN201721375340 2017-10-24
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CN201810509256.3A Active CN108652791B (en) 2017-10-24 2018-05-24 Conveying device capable of repeatedly positioning interventional heart valve
CN201820781988.3U Withdrawn - After Issue CN207871027U (en) 2017-10-24 2018-05-24 A kind of conveying device of the repeatable positioning of intervention heart valve

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CN108652791A (en) * 2017-10-24 2018-10-16 杭州启明医疗器械有限公司 A kind of conveying device of the repeatable positioning of intervention heart valve
CN109692057A (en) * 2017-10-24 2019-04-30 杭州启明医疗器械股份有限公司 A kind of intervention apparatus conveying device convenient for recycling control

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CN117481868A (en) * 2017-10-24 2024-02-02 杭州启明医疗器械股份有限公司 Conveying device of interventional heart valve

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Publication number Priority date Publication date Assignee Title
CN108652791A (en) * 2017-10-24 2018-10-16 杭州启明医疗器械有限公司 A kind of conveying device of the repeatable positioning of intervention heart valve
CN109692057A (en) * 2017-10-24 2019-04-30 杭州启明医疗器械股份有限公司 A kind of intervention apparatus conveying device convenient for recycling control
CN108652791B (en) * 2017-10-24 2023-09-22 杭州启明医疗器械股份有限公司 Conveying device capable of repeatedly positioning interventional heart valve

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Granted publication date: 20180918

Effective date of abandoning: 20230922

AV01 Patent right actively abandoned

Granted publication date: 20180918

Effective date of abandoning: 20230922