CN101588769B

CN101588769B - Knitted stent jackets

Info

Publication number: CN101588769B
Application number: CN2007800466974A
Authority: CN
Inventors: 阿瑟·霍尔茨; 埃里·拜尔; 奥菲尔·帕兹
Original assignee: InspireMD Ltd
Current assignee: InspireMD Ltd
Priority date: 2006-10-18
Filing date: 2007-10-18
Publication date: 2012-10-10
Anticipated expiration: 2027-10-18
Also published as: CN101588769A; CN101563129A; CN101563049A; CN101563129B; CN101563049B

Abstract

The invention discloses an assembly for opening a vessel lumen comprising a radially expandable stent configured to open a vessel lumen, the radially expandable stent comprises a curved wall having a proximal portion, a distal portion and a lumen connecting the proximal portion and the distal portion. The assembly further comprises a knitted jacket comprising a plurality of interconnected loops, the knitted jacket further comprising a tubular wall that substantially surrounds an exterior surface of the radially expandable stent, and at least one retainer belt that slidingly passes through at least one knitted loop of the plurality of interconnected loops in the knitted jacket.

Description

The support casing of braiding

Related application

The application requires the rights and interests of the priority of following U.S. Provisional Patent Application: in the 60/852nd, No. 392 of submission on October 18th, 2006; In the 60/877th, No. 162 of December in 2006 submission on the 27th; And in the 60/860th, No. 485 of submission on November 22nd, 2006.The content of all above-mentioned files is incorporated at this as stating equally fully by reference.

Invention field and background

The present invention; In its some embodiment; Relate to support and support casing assembly (stent jacketassembly); And more specifically but not exclusively, relate to and be designed to damage and prevent that simultaneously embolic debris (embolitic debris) is released into the low volume support casing (lowbulk stent jacket) in the systemic circulation in that support is anti-between expansionary phase.

Used in the stenotic vessels system of treating support to prevent that restenosis from starting from afterwards 1994 of U.S. food and drugs administration approved Palmaz-Schatz support.

Support by elastomeric material and/or plastic material are processed is normally expanded through capsule is expanded.After the support expansion, capsule is dwindled, and it is removed from vascular system, support is then stayed the original place.The support that contains elastic material, the support that for example contains Nitinol (nitinol) is placed in the sheath, passes vascular system, release and the simultaneously expansion of this sheath indentation to allow support.

Though support forms the long-term blood flow that improves, reach period following closely between resting period at support, support is followed serious problem.Support is by producing fragment in the stenotic tissue, this fragment gets in the systemic circulation and moves to extremely important organ, and for example brain and/or lung cause angiemphraxis, tissue necrosis and/or death.The generation of fragment is that all supports are peculiar, comprises being used for morbus cardiacus, carotid artery, degeneration saphenous vein graft and being used for the support that the thrombosis sexually transmitted disease (STD) relevant with acute coronary syndrome becomes.

Related all relevant with supporting structure between support and the life-threatening fragment with vascular environment.The narrow blood vessel of support expansion place normally is arranged in by frangible relatively speckle.Conventional support normally constitutes by having material big reticulated cell, relative stiffness, when vertically shrink between expansionary phase at support in said hole, and the blood vessel around the scraping.

The speckle that stretches out bracket holes partly receives shearing force and is torn pine, produces fragment, and this fragment gets in the systemic circulation through support chamber (lumen).

In order to reduce the amount that gets into the circulation fragment, support launches with support casing usually, and said support casing is processed by the material with aperture.Support casing is usually by comprising, especially, following method forms: double rib knitting (interlocked knitting), weave, interweave and/or porous mould (porousmold) is immersed one or more reagent.

Generally speaking, have the support (jacketed stent) of cover can produce such problem: the flare factor of cover is different with the flare factor of the support that is associated usually.Cover is positioned at the outside of support, and here, cover prevents fragment to greatest extent, and cover must be fixed to support, during launching at support, keeps correct positioning.The difficulty that the cover that will have first flare factor is fixed to the support with second flare factor has stoped at support outer setting cover basically.

Summary of the invention

Therefore the present invention provides a kind of support casing (single fiber knitted stentjacket) of ultimate fibre braiding, and it is around the outer surface of expansible support radially, and with retainer belt prevent to reel off raw silk from cocoons (run).Retainer belt for example passes the key ring (key loop) at an end place of cover slidably, so that when the key ring is drawn, related retainer belt prevents the generation of reeling off raw silk from cocoons.

In other embodiments, retainer belt is crossed selected ring, to produce reel off raw silk from cocoons (the planned run) that designed that will in cover, produce between expansionary phase.Reeling off raw silk from cocoons of being designed allows the support casing expansion, remains on simultaneously on the required material volume of expansion.

In embodiments; Fiber (run fiber) passes the intravasation chamber, hole in the support and produces the blood flow disorder of not expecting in order to prevent to reel off raw silk from cocoons; The fiber that vertically reels off raw silk from cocoons is included in along in the route that reels off raw silk from cocoons that designs on the bracket holes, this fiber is remained on the outside in said chamber.

For protective sleeve does not cause damage owing to its flare factor is different with the flare factor of support, the support casing of braiding is fixed to support slidably so that the expansion of cover does not rely on support.

According to an aspect of the present invention; A kind of assembly that is used to open lumen of vessels is provided; It is included as the radially expansible support of opening lumen of vessels and disposing, this radially expansible support comprise have portions of proximal, the curved wall in distal part and the chamber that is connected portions of proximal and distal part.

Said assembly also comprises the cover of the braiding of the ring that comprises a plurality of interconnection, and the cover of this braiding also comprises basically around the tubular wall of the outer surface of expansible support radially.

Said assembly also comprises at least one retainer belt, and this retainer belt is passed in the ring of at least one braiding in the ring of the said a plurality of interconnection in the cover of braiding slidably.

In embodiments, at least a portion of the cover of said braiding is woven by ultimate fibre.

In embodiments, at least a portion of the cover of said braiding is to be woven by the ultimate fibre that contains multifilament (multiplefilaments).

In embodiments, said at least one retainer belt comprises at least one circumferential part, and this is circumferentially partly circumferentially around passing through radially expansible support.

In embodiments, said at least one retainer belt comprises the retainer belt part that at least one is folding, and this at least one folding retainer belt partly comprises the retainer belt fold (retainer belt fold) in the chamber that extends to expansible support radially.

In embodiments, when radially expansible support was in collapsed configuration, said at least one folding retainer belt part operationally was associated with the inwall of said radially expansible support.

In embodiments, said support comprises the self expandable support.In embodiments, said assembly comprises the part of the conduit of arranging along the chamber of said self expandable support (catheter), so that folding retainer belt partly is crushed between the part of curved wall and said conduit of self expandable support.

In embodiments, said assembly is set to so that in cover when expansion of braiding, and the part of said at least one folding retainer belt part is pulled to operationally be associated (the operative association) that breaks away from the interior section of said curved wall.In embodiments, after the cover expansion of braiding, said at least one folding retainer belt part is circumferentially around at least a portion of said self expandable support.

In embodiments; Said assembly comprises the have inflatable tip ductus bursae (balloon catheter) of (inflatable tip); Said ductus bursae is radially expansible support arrangement basically, so that in a single day expand, the capsule tip just makes said radially expansible support radially outward expand.

In embodiments, when said assembly was set to box lunch that radially expansible support is in collapsed configuration, capsule was set to press said at least one folding retainer belt part to the interior section of the curved wall of expansible support radially.

In embodiments, when cover when expansion of braiding, the part of said at least one folding retainer belt part is pulled to and breaks away from and operationally being associated of the interior section of said curved wall.

In embodiments, after the cover expansion of braiding, said at least one folding retainer belt part is circumferentially around at least a portion of expansible support radially.

In embodiments, at least a portion of said at least one retainer belt comprises elastomeric material.

In embodiments, said at least one retainer belt passes at least one in the ring of a plurality of interconnection in the proximal portion of cover of braiding.

In embodiments, said at least one retainer belt passes at least one in the ring of a plurality of interconnection in the extremity office of cover of braiding.

In embodiments, said at least one retainer belt is in the portions of proximal of the cover of braiding and at least one in the ring that the midway between the distal part is passed a plurality of interconnection.

In embodiments, said at least one retainer belt comprises nearside retainer belt part, distally retainer belt part, and center retainer belt part therebetween.Said at least one retainer belt portions of proximal is connected to the cover portions of proximal of braiding, and said at least one retainer belt distal part is connected to the cover distal part of braiding.

In embodiments, the part location of said at least one folding retainer belt part retainer belt part along the center.

In embodiments, comprise at least one limiter that operationally is associated with said at least one folding retainer belt part, said at least one folding retainer belt part remains on folded configuration through this at least one limiter.

In embodiments, said at least one limiter is slidingly attached to said at least one folding retainer belt part.

In embodiments, said at least one limiter is selected from the group of the limiter that comprises binding agent, band, ring, bail and suture.

In embodiments, said assembly was set to box lunch expansible support when expansion radially, and said at least one folding retainer belt partly is pulled to and breaks away from and operationally being associated of said at least one limiter.

In embodiments, when said assembly was set to box lunch that radially expansible support is in expanded configuration, said retainer belt formed basically the helical form around the cover of braiding.

In embodiments, said assembly comprises the ductus bursae with inflatable tip, and said ductus bursae operationally is associated with expansible support radially, so that in case expand, the capsule tip just makes said radially expansible support radially outward expand.

In embodiments, the ring of said a plurality of interconnection comprises the ring of at least three interconnection, i.e. at least one first ring, at least one second ring and at least one the 3rd ring.

In embodiments, the loop mapping of said at least three interconnection is in the terminal part office of the cover of braiding.

In embodiments, said at least one retainer belt comprises at least a portion of passing said at least one first ring, cross said at least one second ring and passing said at least one the 3rd ring and weaving.

In embodiments, between expansionary phase, said at least one second ring is set in the cover of braiding, produce and reels off raw silk from cocoons longitudinally basically at said radially expansible support.

In embodiments; Said assembly also comprises at least one supporter that reels off raw silk from cocoons (run support); Said at least one supporter that reels off raw silk from cocoons is set to operationally be associated with reeling off raw silk from cocoons of producing, and gets into the radially chamber of expansible support to prevent filamentary at least a portion.

In embodiments, said at least one supporter that reels off raw silk from cocoons comprises and at least one line (cord) of the substantially parallel extension of longitudinal axis of expansible support radially.

In embodiments, said at least one line operationally is associated with the outer surface of expansible support radially.

In embodiments, said at least one line comprises portions of proximal, and this portions of proximal is connected to the portions of proximal of the cover of braiding.

In embodiments, said at least one line comprises distal part, and this distal part is connected to the distal part of the cover of braiding.

In embodiments, said at least one line comprises core, and this core is connected to the core of the cover of braiding.

In embodiments, said at least one supporter that reels off raw silk from cocoons comprises at least one bar, and said at least one bar is connected to radially expansible support.

In embodiments, said radially expansible support comprises the self expandable support.

In embodiments, said assembly comprises the cover buffer element of at least one braiding that operationally is associated with the cover of braiding.

In embodiments, said at least one cover buffer element is substantially parallel with the longitudinal axis in the chamber of expansible support radially.

In embodiments, said radially expansible support is arranged in the compression sheath (compression sheath) movably.

In embodiments, said at least one cover buffer element extends along the outer surface of the cover of braiding, and is set to make the cover of braiding obtain buffering to moving of compression sheath.

In embodiments, said at least one cover buffer element is connected to the part of outer surface of the cover of braiding.

In embodiments, said at least one cover buffer element comprises at least one line.

In embodiments, said at least one cover buffer element extends along the inner surface of the cover of braiding, and is set to make the cover of braiding obtain buffering to moving of expansible support radially.

In embodiments, said radially expansible support is arranged in the compression sheath movably.

In embodiments, said at least one cover buffer element comprises at least one extension of compressing sheath, said at least one extension be arranged on braiding cover at least a portion and radially between at least a portion of expansible support.

In embodiments, said at least one cover buffer element comprises the substantially parallel curved wall of outer surface with the compression sheath, and extends from the interior section of compression sheath.

In embodiments, said compression sheath is supporting support holding device (stent holding apparatus) and is compressing radially at least a portion of expansible support.

In embodiments, said compression sheath between the expansionary phase of expansible support radially with respect to radially moving to the expansible support distally.

According to a further aspect in the invention, a kind of radially method of expansible support that is used to make is provided, said radially expansible support has the cover of the braiding that is connected to it slidably, and said method comprises: radially expansible support is provided; Distensible capsule is positioned in the expansible support; The tubular casing of braiding operationally is associated with said support, and the tubular casing of said braiding comprises the end portion ring of at least two braidings; And the end portion ring that retainer belt is passed said at least two braidings.

Said method also comprises: between the end portion ring of said at least two braidings, in retainer belt, form folding retainer belt part; Said folding retainer belt partly is positioned between the part and said support of conduit; And the said location that keeps said folding retainer belt part through the radially outer pressure that the said part of said conduit is being supported said support.

In embodiments, the step that operationally is associated of the tubular casing of said braiding comprises that the tubular casing with said braiding is positioned at the outside of said support.

In embodiments, at least a portion of the cover of said braiding is to be woven by the ultimate fibre that comprises multifilament.

According to a further aspect in the invention; A kind of assembly that is used to open lumen of vessels is provided; It is included as the radially expansible support of opening lumen of vessels and disposing, said radially expansible support comprise have portions of proximal, the curved wall in distal part and the chamber that is connected portions of proximal and distal part; The support casing that comprises tubular wall, said tubular wall are basically around the outer surface of said radially expansible support; And at least one buffer element that operationally is associated with said cover.

In embodiments, the longitudinal axis in the chamber of said at least one buffer element and said radially expansible support is substantially parallel.

In embodiments, said at least one buffer element extends along the outer surface of said support casing, and is set to make said support casing obtain buffering to moving of said compression sheath.

In embodiments, said at least one buffer element is connected to the part of the outer surface of said support casing.

In embodiments, said at least one buffer element comprises at least one line.

In embodiments, said at least one line comprises portions of proximal, and this portions of proximal is connected to the portions of proximal of said support casing.

In embodiments, said at least one line comprises distal part, and this distal part is connected to the distal part of said support casing.

In embodiments, said at least one line comprises core, and this core is connected to the core of said support casing.

In embodiments, said support casing comprises the material of processing through the technology that is selected from the group of being made up of following technology: interweave knitting (interlacing knitting), double rib be knitting, weave, interweave and/or the porous mould is immersed one or more reagent.

In embodiments, said support casing comprises elastomeric material.

In embodiments, said elastomeric material comprises rubber.

In embodiments, at least a portion of the cover of said braiding fibrage of processing by multifilament.

In embodiments, said at least one buffer element extends along the inner surface of said support casing, and is set to make said support casing obtain buffering to moving of expansible support radially.

In embodiments, said radially expansible support is arranged in the compression sheath movably, and said at least one buffer element comprises and the substantially parallel curved wall of the outer surface of said compression sheath.

In embodiments, said compression sheath and said at least one buffer element between the expansionary phase of said radially expansible support with respect to radially moving the expansible support nearside.

In embodiments, said at least one buffer element comprises at least one extension of compressing sheath, and said at least one extension is positioned at least a portion of support casing and radially between at least a portion of expansible support.

In embodiments, said at least one buffer element is supporting the support holding device and is compressing radially at least a portion of expansible support.

In embodiments, said support casing comprises the made material of technology that is selected from by the following technology group of forming: interweave knitting, double rib is knitting, weave, interweave and/or the porous mould is immersed one or more reagent.

In embodiments, at least a portion of the cover of said braiding is to be woven by the ultimate fibre that contains multifilament.

In embodiments, said support casing comprises elastomeric material.

In embodiments, said elastomeric material comprises rubber.

In accordance with a further aspect of the present invention; A kind of assembly that is used to open lumen of vessels is provided; It is included as the radially expansible support of opening lumen of vessels and disposing; This radially expansible support comprise have portions of proximal, the curved wall in distal part and the chamber that is connected portions of proximal and distal part, this radially expansible support be arranged on movably in the compression sheath.

Said assembly also comprises the cover of the braiding that comprises tubular wall; Said tubular wall is basically around the outer surface of expansible support radially; The cover of said braiding comprises the ring of at least three interconnection, i.e. at least one first ring, at least one second ring and at least one the 3rd ring.

Said assembly also comprises at least one retainer belt; Said at least one retainer belt has at least one part of passing said at least one first ring, walk around said at least one second ring and passing said at least one the 3rd ring and weaving, in case said at least one second ring is set to radially expansible support expansion then in the cover of braiding, produces reel off raw silk from cocoons.

In embodiments, the loop mapping of said at least three interconnection is in the terminal part office of the cover of said braiding.

In embodiments, said assembly also comprises at least one supporter that reels off raw silk from cocoons, and the said supporter that reels off raw silk from cocoons is set to operationally be associated with reeling off raw silk from cocoons of producing, and prevents that at least a portion of fiber from getting into the chamber of said radially expansible support.

In embodiments, said at least one supporter that reels off raw silk from cocoons comprises at least one line that extends along the outer surface of said support.

In embodiments, said at least one line operationally is associated with the outer surface of said radially expansible support.

In embodiments, said at least one line comprises portions of proximal, and this portions of proximal is connected to the portions of proximal of the cover of said braiding.

In embodiments, said at least one line comprises distal part, and this distal part is connected to the distal part of the cover of said braiding.

In embodiments, said at least one line comprises core, and this core is connected to the core of the cover of said braiding.

In embodiments, said at least one supporter that reels off raw silk from cocoons comprises at least one bar that is connected to said radially expansible support.

In accordance with a further aspect of the present invention, a kind of method that in the controlled at least a portion at support casing of reeling off raw silk from cocoons of radial support chien shih expansionary phase, forms is provided, this method comprises: radially expansible support is provided; Woven tubular cover, said tubular casing comprise the end portion ring of at least three braidings, i.e. at least one first ring, at least one second ring and at least one the 3rd ring; And the tubular casing of said braiding operationally is associated with said support.

Said method also comprises: pass said at least one first ring, cross said at least one second ring and pass said at least one the 3rd ring and the braiding retainer belt; Expand said radially expansible support; And at least one controlled support of formation reels off raw silk from cocoons in part cover and that said at least one second ring is associated of said braiding.

In embodiments, said method comprises: at least one support component operationally is associated with said at least one second ring.In embodiments, said method comprises: at least one support component operationally is associated with the tubular casing of said braiding.

In embodiments, said at least one support component comprises at least one Support Level.In embodiments, said method comprises: said at least one line operationally is associated with the outer surface of said radially expansible support.In embodiments, said at least one support component comprises at least one support bar.In embodiments, said method comprises: a said support bar operationally is associated with said radially expansible support.

In accordance with a further aspect of the present invention, a kind of method that is used at support cover on the protective cradle between expansionary phase is provided, said method comprises: radially expansible support is provided; Tubular casing operationally is associated with said support; And at least one buffer element operationally is associated with said cover.

In embodiments, said at least one buffer element is set to make said support casing obtain buffering to moving of said radially expansible support.In embodiments, said at least one buffer element comprises at least one line.

In embodiments, said at least one buffer element is set to make said support casing obtain buffering to moving of compression sheath.In embodiments, said at least one buffer element comprises at least one extension of compressing sheath.In embodiments, said at least one extension is arranged between at least a portion of at least a portion and said radially expansible support of said support casing.In embodiments, said at least one buffer element is supporting at least a portion of the said radially expansible support of support holding device compression.

In accordance with a further aspect of the present invention; A kind of assembly that is used to open lumen of vessels is provided; This assembly comprises: for opening the radially expansible support that lumen of vessels disposes, said radially expansible support comprise have portions of proximal, the curved wall in distal part and the chamber that is connected said portions of proximal and distal part; And the support casing that comprises tubular wall, said tubular wall is basically around the outer surface of said radially expansible support.Said assembly also comprises the compression sheath, and said radially expansible support is arranged in this compression sheath movably, and said compression sheath comprises at least one radio opaque markers thing.

In embodiments, said at least one radio opaque markers thing is positioned on the distal part of said compression sheath.

In embodiments, navigate to the distal part of said compression sheath said at least one radio opaque markers thing nearside.

In embodiments, on said support casing, comprise at least one radio opaque markers thing.

In embodiments, said at least one radio opaque markers thing is positioned on the portions of proximal of said support casing.

In embodiments, said at least one radio opaque markers thing is from ground, the portions of proximal distally skew of said support casing.

In embodiments, said at least one radio opaque markers thing is positioned on the distal part of said support casing.

In embodiments, said at least one radio opaque markers thing is from the distal part nearside ground skew of said support casing.

In embodiments, said assembly comprises at least one extension of said compression sheath, and said at least one extension is positioned between at least a portion of at least a portion and said radially expansible support of said support casing.

In embodiments, said radially expansible support comprises the metal ingredient (metallic base) that is selected from the group of being made up of following material: rustless steel, Nitinol, tantalum, MP35N alloy, cobalt-base alloys, platinum, titanium or other biocompatible metals alloy.

In embodiments, but said radially expansible support comprise the composition of the biodegradable/bio-absorbable that is selected from the group of forming by following material: PGLA, PLLA, PLA, can biological resorbent magnesium, or other can biological resorbent chemical compound.

In embodiments, said compression sheath comprises that thickness is at least about 0.2 millimeter wall.

In embodiments, said compression sheath comprises that thickness is greater than about 0.5 millimeter wall.

In embodiments, the cover of said braiding, compression sheath, support holding device, buffer element, check strap (restrainer belt) and woven belt (woven belt) comprise the material that is selected from the group of being made up of polyethylene, polrvinyl chloride, polyurethane and nylon.

In embodiments, the cover of said braiding, compression sheath, support holding device, buffer element, check strap and woven belt comprise the material that is selected from the group of being made up of following material: Nitinol, rustless steel shape-memory material, metal, synthetic Biostatic polymer, natural polymer and inorganic material.In embodiments, said Biostatic polymer comprises the material that is selected from the group of being made up of following material: polyolefin, polyurethane, fluorinated polyolefin, chloridized polyolefin, polyamide, acrylate polymer, acrylamide polymer, polyvinyl, polyacetals, Merlon, polyethers, polyester, aromatic polyester, polysulfones and silicone rubber.

In embodiments, said natural polymer comprises the material that is selected from the group of being made up of following material: polyolefin, polyurethane, Mai La (Mylar), polysiloxanes and fluorinated polyolefin.

In embodiments, the cover of said braiding, compression sheath, support holding device, buffer element, check strap and woven belt comprise the material with the character that is selected from the group of being made up of following character: flexible, flexible, plasticity and rigidity.

In embodiments, said capsule comprises biocompatible elastomeric material or half flexible material, for example: rubber, silicone rubber, latex rubber, polyethylene, PETG, Mai La and/or polrvinyl chloride.

In embodiments, the swell diameter of said capsule depends on the diameter of section in chamber between 1.5 millimeters to 6.0 millimeters.In bigger blood vessel, said capsule and filter are randomly processed has bigger maximum gauge.In less blood vessel, for example, possibly expect less maximum gauge, thereby less reduce the material of support and filter for the support that reduces to shrink and the volume of filter.

In accordance with a further aspect of the present invention; A kind of assembly that is used to open lumen of vessels is provided; It comprises: for opening the radially expansible support that lumen of vessels disposes, said radially expansible support comprise have portions of proximal, the curved wall in distal part and the chamber that is connected said portions of proximal and distal part; The cover that comprises tubular wall, said tubular wall are basically around the outer surface of said radially expansible support; And at least one retainer belt, it comprises at least two parts: i.e. at least one first and at least one second portion, and this at least one first passes at least a portion of the tubular wall of said cover slidably; And this at least one second portion comprises at least one folding retainer belt part in the chamber that extends to said radially expansible support.

In embodiments, at least a portion of blood vessel is narrow.In embodiments, said blood vessel comprises tremulous pulse.

In embodiments, said at least one retainer belt comprises at least one circumferential part, and said at least one circumferential part is circumferentially around passing through said radially expansible support.In embodiments, when expansible support was in collapsed configuration, said at least one folding retainer belt part operationally was associated with the inwall of said radially expansible support said radially.

In embodiments, said support comprises the self expandable support.In embodiments, said assembly comprises the duct portion of arranging along the chamber of said self expandable support, so that a folding retainer belt partly is crushed between the curved wall and said duct portion of said self expandable support.

In embodiments, when said assembly was set to the expansion of the said cover of box lunch, the part of said at least one folding retainer belt part was pulled to and breaks away from and operationally being associated of the interior section of said curved wall.In embodiments, after the expansion of said cover, said at least one folding retainer belt part is circumferentially around at least a portion of said self expandable support.In embodiments, said assembly comprises the ductus bursae with inflatable tip, and said ductus bursae is arranged along the chamber of said radially expansible support basically, so that in a single day expand, said capsule tip just makes said radially expansible support radially outward expand.

In embodiments, said assembly is set to box lunch said radially when expansible support is in collapsed configuration, and said capsule is set to press said at least one folding retainer belt part to the interior section of the curved wall of said radially expansible support.

In embodiments, when said assembly was set to the expansion of the said cover of box lunch, the part of said at least one folding retainer belt part was pulled to and breaks away from and operationally being associated of the interior section of said curved wall.

In embodiments, after the expansion of said cover, said at least one folding retainer belt part is circumferentially around at least a portion of said radially expansible support.

In embodiments, the cover of said support comprises by being selected from the made material of following technology: interweave knitting, double rib is knitting, weave, interweave and/or the porous mould is immersed one or more reagent.In embodiments, the cover of said support comprises elastomeric material.In embodiments, said elastomeric material comprises rubber.

In accordance with a further aspect of the present invention, a kind of assembly that is used to open narrow tube chamber is provided, this assembly comprises: for opening the radially expansible support that narrow tube chamber disposes, said radially expansible support comprises the curved wall with outer surface; And the cover that comprises the curved wall with inner surface, said inner surface is supporting the outer surface of said support movably and is placing side by side.

In embodiments, said assembly comprises that the part with said cover is connected at least one adapter of support.In embodiments, being connected between cover and the filter appears at the cover and the portions of proximal of filter.In embodiments, being connected between cover and the filter appears at the cover and the distal part of filter.

In embodiments, said assembly comprises fold in cover, and said fold is folded on the inner surface of support.In embodiments, the said fold in the cover operationally is associated with the near-end of support.In embodiments, the said fold in the cover operationally is associated with the far-end of support.

Before specifying at least one embodiment of the present invention, should be understood that the present invention is not necessarily limited to proposed in the following description on it is implemented and/or cited composition and/or the CONSTRUCTED SPECIFICATION and the arrangement mode of method in accompanying drawing and/or embodiment.The present invention can adopt other embodiment or can implement in every way or carry out.

Only if in addition definition, employed all technical terms of this paper and/or scientific terminology have with the present invention under the identical meanings of those of ordinary skill common sense in the field.Although in the enforcement of embodiment of the present invention or test, can use and similar or the method and the material that are equal to described herein, method that following description is exemplary and/or material.If conflict, patent specification comprises definition, will account for leading.In addition, material, method and embodiment are illustrative, and do not mean that essential restrictive.

Description of drawings

Only, embodiments more of the present invention have been described at this with the form of instance and with reference to accompanying drawing.At present will be at length specifically with reference to accompanying drawing, stress that here the details that is shown is with the form of instance and is to discuss purpose for the illustrative of embodiment of the present invention.In this, but make to those skilled in the art that with reference to the description of accompanying drawing how the embodiment of embodiment of the present invention becomes obvious.

In the accompanying drawings:

Fig. 1-8 has shown the expansion of capsule expansible support (balloonexpandable stent) and the grip assembly of braiding according to embodiments of the present invention;

Fig. 9-19 has shown according to embodiments of the present invention the radially expansion of the grip assembly of expansible support and braiding; With

Figure 20 a-20f has shown according to embodiments of the present invention, has had the support of the cover that connects movably.

The description of preferred embodiment

The present invention relates to be positioned at support outside and quilt protection to prevent the support casing of its damage during launching at support.

With reference to following explanation, accompanying drawing and embodiment, can understand the principle and the purposes of the present invention's instruction better.In the accompanying drawings, identical label refers to identical parts all the time.

Before specifying at least one embodiment of the present invention, should be understood that the present invention is not limited to the details that proposes at this in it is used.The present invention can adopt other embodiment to realize and can implement in various manners or carry out.

It is also understood that wording that this paper adopts and term be should not be regarded as for purpose of description restrictive.

Only if in addition definition, employed all technical terms of this paper and scientific terminology have with the present invention under the identical meanings of those of ordinary skill common sense in the field.In addition, explanation, material, method and instance only are illustrative, are not that to be intended to be restrictive.Can be used in enforcement of the present invention and the test with method and material similar or that be equal to described herein.

As used herein term " comprises " and " comprising " or their grammatical variants should be regarded as specifying characteristic, integral body, step or the component of being stated but not get rid of and add one or more additional features, integral body, step, component or its combination.These terms contain term " by ... form " with " basically by ... composition ".

This paper employed " one (a) " or " one (an) " are meant " at least one " or " one or more ".The use of phrase " one or more " does not change the original implication of " one (a) " or " one (an) " among this paper.

Fig. 1 has shown the sketch map of the assembly 100 that is used to open blood vessel 127, this assembly 100 comprise by cover 130 around capsule expansible support 146.Cover 130 is positioned at the tissue that to protect blood vessel 127 on the outside of support 146 at support between 146 expansionary phases.

In addition, cover 130 is positioned on the outside of support 146 can provide firm protection, prevents that potential fragment 121 is in support intravasation chamber 125 between 146 expansionary phases.

Fig. 2 has shown and has overlapped 130 details that cover 130 is shaped as the tubular structure of the ring 270 that comprises a plurality of interconnection.

Assembly 100 comprises conduit capsule (catheter balloon) 106, and conduit capsule 106 impels expansible support 146 expansions when expansion, thus expanding sheath 130.

Assembly 100 also comprises retainer belt 160, and retainer belt 160 circumferentially passes ring 270, thereby in the location of support 146 and/or between expansionary phase, prevents in cover 130, to form and reel off raw silk from cocoons.

In embodiments, retainer belt 160 withdraws from ring 270 to form folding retainer belt part 168.As finding out best among Fig. 1; When capsule 106 was in the configuration of not expanding, folding retainer belt part 168 was wedge shapes, is located between capsule 106 and the support 146 at this; Thereby will overlap 130 correct positions that are maintained slidingly retained in around support 146, and need not other fixture.

Distensible cover 130 randomly has the flare factor different with support 146, but owing to be slidingly connected, and support 146 is with the friction speed expansion, and does not influence the expansion of distensible cover 130.In this way, distensible cover 130 is easy to closely remain on the outer surface of support 146, prevents effectively in the narrow fragment 121 intravasation chambeies 125 thereby be positioned in certain embodiments.

Below will discuss the selectable configuration of the support 146 that is slidably connected to support casing 130 with reference to Figure 20 a-20f.

Though have and singlely folding be with 168, in certain embodiments, possibly need bigger expansion, this makes a plurality of folding retainer belts 168 necessitate.

Fig. 4 a has shown assembly 110; This assembly 110 is included in two folding retainer belt parts 168 that are positioned at the distally between support 146 and the capsule 106; In case support 146 expansions, 168 expansion of two folding retainer belt parts are to form circumferential basically retainer belt 160, shown in previous Fig. 3.The retainer belt part 168 in two folding distally randomly provides better stability to the cover on the support 146 130 and/or allows the length of each folding retainer belt part 168 to have shorter length, allows cover 130 outward radial expansion fully simultaneously.

In certain embodiments, for example when the place, two ends at support 146 all needs the controlled expansion of support casing 130, possibly need alternative position of two folding retainer belt parts 168.

Fig. 4 b has shown the assembly 120 that comprises two retainer belts 160, and two retainer belts 160 are located along proximal ring and distal 270, thereby in the location of support 146 and/or between expansionary phase, prevents to reel off raw silk from cocoons in the formation of arbitrary terminal part office of cover 130.

In embodiments, randomly,,,, prevent for example reeling off raw silk from cocoons of producing by the tear in the cover 130 so that extra protection to be provided around cover 130 fixing one or more retainer belts 160 basically in the centre of cover 130.Position and configuration that many kinds of retainer belt 160 are possible are known those of ordinary skill in the art.

In embodiments, be desirably in and guarantee level and smooth moving during retainer belt 168 launches.

Fig. 4 c has shown the plane graph of carriage assembly 150 embodiments that comprise self expandable support 146, and wherein support casing 130 is under support 146.For the sake of clarity, support casing 130 is shown in the distally slightly of support 146.Folding retainer belt part 168 along support bar 387 on support 146.Support bar 387 allows folding retainer belt 168 smoothly to move between 146 expansionary phases at support, and is not blocked by the rhombus pole of support 146.

In order to make support 146 and cover 130 form tubular assembly 150, edge 147 is combined on direction 421 with edge 149.

Though support casing 130 is presented on the capsule expansible support, support casing 130 can randomly be arranged for the support of other type, and allows the configuration that is slidingly connected between support casing 130 and the support 146 simultaneously.

In Fig. 4 d, tubular bracket assembly 150 is presented at the position around mandrel carriage (spindle holder) 180, and from compression sheath 182, exposes, and support 146 is arranged with cover 130 basically in a tubular form.Folding retainer belt part 168 is being supported the inner surface location of support 146, and remains on the appropriate location through the pressure of mandrel carriage 180; Even support casing 130 is positioned on the outer surface of support 146 slidably, guarantee that also support casing 130 assemblies remain on the support 146.

In assembly 110, between expansionary phase, folding retainer belt 168 is zoomed out through the ring 270 that overlaps 130 front, so that like finding among Fig. 4 e, assembly 150 is expanded in lumen of vessels 125 fully, and overlaps 130 and pressing blood vessel wall 127.

In embodiments; Though with 160 be shown as the cover 146 that passes braiding ring 270; Cover 130 comprises woven fabric (woven fabric); Rather than knitted fabric (knit fabric), and folding retainer belt part 168 is that to pass first and the second portion of cover 130 woven, the retainer belt part 168 that folds simultaneously is arranged between the first and second portion of said woven fabric.

In other embodiments; Cover 130 comprises the porous chips that contains such as elastomeric material; And pass cover 130 first and second portion with 160 and do ring formation; Folding simultaneously band portion 168 is arranged between first loop section and second loop section, passes cover 130 and is supporting the inner surface of support 146.Being suitable for overlapping many types of material of 130 knows those of ordinary skill in the art with many configurations of the folding band portion 168 that passes cover 130.

In the embodiment of above-mentioned assembly 100, assembly 110, assembly 120 and assembly 125; Being provided with of folding retainer belt part 168 allows cover 130 on support 146, to move slidably, and need not binding agent, woven or sew up the fabric of the outer surface fixed cover 130 that is supporting support 146.In this way, between expansionary phase, outside localized support casing 130 is independent of support 146 expansions, and easily slides with respect to support 146.Although support 146 has different flare factors with cover 130, in this way, as stated, support 146 can work with cover 130 effectively.

In addition, in embodiments, the outside that cover 130 is set at support 146, cover 130 prevents that narrow fragment 121 is between expansionary phase in the intravasation chamber 125.

As used herein; Any mentioning to " material of braiding (knitted material) " comprises any material of being made by weaving (knitting process); Especially comprise: by the material of ultimate fibre braiding, its with socks with nylon in employed method similar; The geminal fibers fabric (double fiber knit) that is called as " two braided material "; With any material that is easy to reel off raw silk from cocoons, no matter said reeling off raw silk from cocoons is to come from for example above-mentioned " sth. made by twisting is opened (flipping) " and/or the tear in the main body of material.

In addition; As used herein; To any material that comprises by fibrage of mentioning of " material of braiding ", said fiber is monofilament or multifilament fiber, especially polyethylene, polrvinyl chloride, polyurethane and nylon rustless steel Nitinol or any other the monofilament or multifilament fiber of metal.

In embodiments, folding retainer belt 168 possibly need longer length with when the expansion fully around 146 1 weeks of support.

Fig. 5 has shown the retainer belt 179 that is folded into multiple fold 178.The multiple fold 178 usefulness first and second annular limiters 176 remain on folding configuration.Though described annular limiter 176, be used to keep the selectable embodiment of fold 178 to comprise binding agent, clip, bail and/or suture.Selectively, single limiter 176 randomly is used to fixing removably multiple fold 178.

As seen in fig. 6, first end portion of retainer belt 179 is connected to the distal part of cover 130, and second end portion of retainer belt 179 is connected to the portions of proximal of cover 130.The part that the arbitrary end portion from multiple fold 178 of retainer belt 179 is extended is 270 woven through encircling, thereby protective sleeve 130 does not produce during launching and reels off raw silk from cocoons.

Fig. 7 has shown the multiple fold 178 that remains on folded configuration through two pairs of limiter rings 176 on each fold 178.

As seen in fig. 8; Support 146 has been radially expanded with cover 130; Thereby the retainer belt part with multiple fold 178 has been pulled to and has broken away from limiter ring 176 basically, and retainer belt 179 formation are around the shape of single-screw basically (monotonous helix) of the cover 130 of expansion.

Though when support 146 during in expanded configuration and contraction (Fig. 5) configuration, retainer belt 179 all is shown as helical structure, retainer belt 179 can be randomly in perpendicular to the plane of support 146 longitudinal axis circumferentially radial loop around cover 130.

Selectively, the clockwise helical form that first retainer belt 179 forms around cover 130, and the counterclockwise helical form that second retainer belt 179 forms around cover 130, thus on cover 130, form, for example, one or more " x " pattern.

In addition, at least a portion of retainer belt 179 randomly comprises elastomeric material, and this elastomeric material allows retainer belt 179 expansions to exceed the length that is included in the material in the folded portions 178.The many kinds of configurations and the material of retainer belt 179 are known those of ordinary skill in the art.

Not pipe box 130 be braiding or overlap 130 and make by multiple other technology, all fragile during launching with the cover 130 of self expandable support 146 combinations.For example, as seen in fig. 9, self expandable carriage assembly 200 is comprised in the lumen of vessels 127.Self expandable carriage assembly 200 comprises self expandable support 240 and cover 132, and self expandable support 240 is supporting 180 compressions of mandrel carriage with cover 132 through compression sheath 182.Between expansionary phase, owing to for example on sheath 182, rubbing and/or hanging fiber, cover 132 may be compressed sheath 182 and damage.

Like finding in the side view of the cross-sectional view strength of Figure 10 and Figure 11 A, in order to prevent to be damaged by sheath 182, buffer element 188 is placed into cover 132 and compresses between the sheath 182.

Like finding among Figure 11 B, buffer element 188 prevented compression sheath 182 remove and between expansionary phase of support 240 to overlapping 132 damage.

From Figure 12, can recognize vertical configuration of buffer element 188, its medium-height trestle 240 is expansion fully in lumen of vessels 127.There are many other possible configurations in buffer element 188, and for example helical structure does not show.

In addition, there are a lot of methods that buffer element 188 is fixed to cover 132.For example, like what shown, buffer element 188 comprises the line of the outer surface that is connected to cover 132.Randomly, buffer element 188 is connected the distal part and the proximal portion of cover 132 or support 240.

As used herein, (proximal) of term nearside and nearside ground (proximally) refer in the position of lumen of vessels 127 middle and upper reaches directions respectively and move.As an example, compression sheath 182 is at the nearside of support 240.As used herein, (distal) in term distally and ground, distally (distally) refer in the position of lumen of vessels 127 middle and lower reaches directions respectively and move.As an example, support 240 is in the distally of compression sheath 182.

As stated, support 240 132 has different flare factors usually with cover, but is protected through above-mentioned being slidingly connected.Yet for compression sheath 182, cover 132 is maintained at pressured state, and shifts out compression sheath 182 slidably.Between expansionary phase, different flare factors still possibly have and during the radial dilatation of support 240, cause damaged probability together with the radially inner pressure of sheath 182.

Figure 13 has shown assembly 300, and wherein buffer element pipe 184 is placed between the outer surface of cover 132 inner surface and support 240, to prevent to overlap between expansionary phase 132 damage.

Shown among Figure 14 that support 240 exposes from buffering element tube 184, shown that simultaneously cover 132 exposes between compression sheath 182 and buffer element pipe 184.In this way, as seen in fig. 15, although there is the difference of aforesaid flare factor, support 240 and cover 132 be destructive envelope 132 at lumen of vessels 127 intramedullary expansions and not successfully still.

The suitable location of support 240 is very important, so that support 240 is not blocked for example branch vessel 350.In order to confirm the location of support 240, can label be placed support 240 and/or overlaps on 132.Yet this is always enough not accurate.

For example, if support casing 132 reaches outside the nearside border and/or border, distally of support 240, then the radio opaque markers thing on the support 140 can not provide the positional information about support casing 132 scopes for the surgeon.Therefore, label being placed, for example, is suitable on the positioning equipment.

Like finding among Figure 11,12,13,14 and 15, sheath 182 is randomly incorporated to the distally radio opaque markers thing 177 into.Radio opaque markers thing 177 can for example, for be illustrated in support 240 radial dilatation to the surgeon after, overlap the further position of 132 far-ends randomly to the skew of the distal part nearside ground of sheath 182.

Selectively, support casing 132 comprises the radio opaque markers thing 163 of nearside.Distally label 145 and/or nearside label 163 be respectively with the farthest side border of support casing 132 and/or the surgeon of side, boundary announcement recently, thereby accurate azimuth information is provided for the surgeon.

In embodiments, label 146 is placed on a plurality of positions with label 163, so that more information is offered the surgeon.

For example, radio opaque markers thing 146 can be set to each with radio opaque markers thing 163 and all incorporates two labels into.First label 146 shows the edge of support casing 132, and expression expansion after-poppet 240 will be where.Second label 163 provide about before support 240 expansion, during or the positional information on the border of afterwards support 240.

In this way, the surgeon is not only known cover 132 position, also knows position 240 that provide by support, the supporter below cover 132, and so has avoided obstruction branch vessel 350.

Radio opaque markers thing 163,145 and 177 randomly comprises gold or other radio opaque markers material.

So far, the present invention has concentrated on and has prevented to the damage of the support casing that comprises braided material with in the damage that comprises the cover 132 on the self expandable support of any material.

For the cover 140 of braiding, if can control 198 (Figure 17) that reel off raw silk from cocoons to prevent the mode that fiber gets into the chamber of support 240 basically, then reeling off raw silk from cocoons 198 can randomly help to overlap 130 radial dilatation and volume and reduce.

Figure 16 has shown carriage assembly 400, carriage assembly 400 comprise by controlled reel off raw silk from cocoons 140 of wired tubes around the self expandable support 240 that is shrinking, wherein retainer belt 123 in the back of ring 260, pass second ring 270 and pass through in the front of the 3rd ring 280.

In case support 240 expansion as seen in fig. 17, stop to form with regard to the protection that receives retainer belt 123 and reels off raw silk from cocoons 198 from encircling 270 extended rings in a row.As distinct contrast, be not protected and form and reel off raw silk from cocoons 198 from encircling 260 and 280 extended rings in a row.

For the fiber 199 that prevents to reel off raw silk from cocoons gets into the chamber of supports 240, along from encircling 260 and 280 rings in a row that extend, the Support Level of reeling off raw silk from cocoons 288 is positioned in support 240 and controlled reeling off raw silk from cocoons overlapped between 140.In embodiments, reel off raw silk from cocoons supporter 288 vertically place support 240 and the cover 130 between.

As stated, reel off raw silk from cocoons 198 help to provide support casing 140 remarkable radial dilatation.Do not reel off raw silk from cocoons 198, cover 140 expansion is only encircled 270 radial drawing and is limited.Yet reeling off raw silk from cocoons 198 causes the fiber 199 that laterally reels off raw silk from cocoons that prolongs, thereby the pattern that beyond the stretching of ring 270, obtains radial dilatation is provided.

Compare with the cover of protecting fully with retainer belt 123 140, reel off raw silk from cocoons and 198 reduced the amount that obtains given radial dilatation material requested potentially.Therefore, the controlled cover 140 that reels off raw silk from cocoons has following potentiality: significantly reduce volume, pass through lumen of vessels 127 thereby the assembly 400 that shrinks is operated more easily.

Reel off raw silk from cocoons the connection of supporter 288 can several kinds in the mode any be provided with.In embodiments, the supporter 288 that reels off raw silk from cocoons comprises portions of proximal and distal part, and said portions of proximal is connected to support 240 and/or overlaps 130 portions of proximal, and said distal part is connected to support 240 and/or overlap 130 distal part.In embodiments, the supporter 288 that reels off raw silk from cocoons comprises core, and said core is connected to support 240 and/or overlaps 130 core.

Decapacitation promote to reduce beyond controlled the reeling off raw silk from cocoons of volume, and retainer belt 168 can be set to have the expansion of increase, as previously discussed.For example, in embodiments, retainer belt 123 comprises folding retainer belt part 168 (Figure 16).Between the expansionary phase of self expandable support 240, folding retainer belt part 168 moves on direction 169 and launches, and circumferentially joins to become with retainer belt 123.

In the embodiment that comprises folding retainer belt part 168, retainer belt 123 randomly comprises the material of relative stiffness, and folding retainer belt part 168 provides retainer belt 123 required expansion basically.

In other embodiments, retainer belt 123 comprises can medium tensile material, and this material helps retainer belt 123 with 168 expansions of folding retainer belt part.

In further embodiment, wherein there is not folding retainer belt part 168, retainer belt 123 randomly comprises elastomeric material, and this elastomeric material provides retainer belt 123 whole required expansions between the expansionary phase of self expandable support 240.Many kinds of material property and retainer belt 123 configurations are selected those of ordinary skill in the art are known.

The position and the configuration of 199 supporter of reeling off raw silk from cocoons is not limited to be positioned at the controlled Support Level 288 of reeling off raw silk from cocoons of reeling off raw silk from cocoons between cover 140 and the support 240.Like finding in the plane graph (Figure 18) of assembly 400, the support bar that reels off raw silk from cocoons (run support rail) 388 can be integrated with support 240.

As seen in fig. 19, the supporter 388 that reels off raw silk from cocoons gets into the chamber of support 240 basically along 198 arrangements of reeling off raw silk from cocoons to prevent the above-mentioned fiber that reels off raw silk from cocoons.

As having a situation of Support Level of reeling off raw silk from cocoons 288, the support bar 388 that the reels off raw silk from cocoons fiber 199 that prevents to reel off raw silk from cocoons gets into the chamber of the support of being implanted 240.As distinct contrast, the fiber 288 that reels off raw silk from cocoons that not supported bar 388 supports possibly produce dangerous blood flow disorder and/or thrombosis, as previously discussed.

In embodiments, support 240 comprise the biodegradable material that is selected from the group of forming by following material: PGLA, PLLA, PLA, can biological resorbent magnesium or other biodegradable material.

As used herein, the biodegradable composition of term (biodegradable base) is meant through degraded and/or any material of being absorbed by internal milieu in the environment in vivo after a while.In addition, as used herein, but term biodegradable with the can be biological resorbent of term bio-absorbable with term be interchangeable.

In embodiments, support 240 comprises metal ingredient usually, for example rustless steel, Nitinol, tantalum, MP35N alloy, cobalt-base alloys, platinum, titanium or other biocompatible metals alloy.

In embodiments, support 240 comprises the alloy that contains tantalum, tungsten and zirconium: tantalum is from about 20% to about 40% weight ratio; Tungsten is from about 0.5% to about 9% weight ratio; And zirconium is from about 0.5% to about 10% weight ratio.

In selectable embodiment, self expandable support 240 comprises the alloy with shape memory characteristic such as Nitinol (Ni-Ti alloy).

Marmem has the ultra characteristic that plays, and it allows support 240 during inserting lumen of vessels 127, to be out of shape and is limited on the mandrel 180.When compression sheath 182 is removed (Figure 11), and self expandable support 240 is exposed to suitable following time of temperature conditions, and shape-memory material returns to the configuration of original expanded.For example, self expandable support 240 is being hyperelastic at least about 21 degrees centigrade to not being higher than in about 37 degrees centigrade scope.

As used herein, the term nitinol is meant a kind of alloy, and this alloy comprises the nickel between nickel to no more than about 60 atomic percentages of about at least 50.5 atomic percentages, and the remainder of this alloy is a titanium.The term Nitinol is intended to mean the known memory metal support of above-mentioned two component memory metal supports and any other type.

In embodiments, the cover 130 comprise diameter between at least about 20 microns with no more than about 200 microns hole 270 (Figure 16).In embodiments, all basically holes 270 have similar substantially diameter.In other embodiments, hole 270 has variable diameter.

In embodiments, the cover 130 have between at least about 20 microns with no more than about 200 microns thickness.

In embodiments, the support 240 of expansion does not have at least about 0.3 millimeter to no more than about 3.0 millimeters diameter; And the support 240 of expansion has at least about 1.0 millimeters to no more than 8.0 millimeters diameter.

In embodiments, cover 130 and/or support 240 comprise be used to protect from infection, inflammation, hemopexis and/or one or more active agents coatings of thrombosis purpose and/or the material that soaks into.

In embodiments, the cover 140 that is connected to support 240 movably can be processed by any technology that comprises following technology: knitting, braiding, knotting, circumvolution, interweave, electric spinning and/or the porous mould immersed one or more reagent.

Figure 20 a-20f has shown the support with the cover that connects movably, according to embodiment of the present invention, uses to allow polytype cover material with support 140 unfolded removable connections.

Figure 20 a has shown the support 210 of band cover, and it comprises the outer cover 272 and internal stent 242 that connects through distally connection 290.Like finding among Figure 20 b, except the distally connects 290, support 242 more is not connected with cover 272 basically.

Radially outward between expansionary phase, support 242 significantly shrinks on direction 258 usually on direction 256, keeps static relatively and overlap 272 simultaneously with respect to support 242.Cover 272 allows support 242 to shrink, and cushions the shearing force that in damage 144, is produced by support 242 simultaneously, thereby prevents the generation of fragment undesirable and dangerous during radial dilatation 130 basically.

In embodiments, the distally connect 290 randomly comprise make (sewing), bonding, gummed, sew up, the technology of riveted joint and/or welding.Randomly, the distally connects 290 squints along support 242 nearside ground 164, for example reaches and comprises the center of support 242 or along the distal part of support 242.

Figure 20 c and Figure 20 d have shown the support 300 of band cover, and it is folding on the distal part 162 of support 242 wherein to overlap 272 distal part 162.Therefore, support 242 is not connected to cover 272 basically fully.In radially outward between expansionary phase of direction 256; Support 242 causes the slit 282 between support 242 and support casing 272 in the contraction on the direction 258, thereby obtains buffering by the shearing force of the wall to blood vessel 127 that contraction produced (Fig. 1) of support on direction 258.

Figure 20 e and 20f have shown another kind of embodiment, wherein all folding cover 272 on the support 390 of the band cover nearside 162 that is included in support 242 and distally 164 parts.In case support 242 expansions because cover 272 keeps static basically with respect to the contraction of support 242 on direction 258, randomly form slit, distally 282 and/or nearside slit 284.

In embodiments, cover 272 comprises having between at least about 3 microns holes 244 with no more than about 100 microns diameter.

In embodiments, cover 272 contains porose 244, and it prevents that basically the narrow fragment 121 (Fig. 1) that is produced from getting into hole 244, thereby prevents the tendency that the above speckle of mentioning is torn from lumen of vessels part 140 basically.In embodiments, the hole have between at least about 20 microns with no more than about 210 microns diameter.In embodiments, porose 244 have similar substantially diameter.In other embodiments, hole 244 has variable diameter.

The carriage assembly of above-mentioned band cover comprises assembly 100,110,120,150,200,210,220,290,300 and 400, randomly is designed for various vascular tissues, comprises crown, periphery, brain and/or carotid vascular tissue.In addition, the carriage assembly of above-mentioned band cover randomly is designed for treatment aortic aneurysm and/or body cavity, for example relevant with lung tissue chamber.

Many materials, method for preparing, purposes and the design of the carriage assembly of above-mentioned band cover are concerning those of ordinary skill in the art, to know.

In embodiments, the cover of braiding, compression sheath, mandrel, buffer element, retainer belt and woven belt comprise the material that is selected from the group of being made up of polyethylene, polrvinyl chloride, polyurethane and nylon.

In embodiments, the cover of braiding, compression sheath, mandrel, buffer element, check strap and woven belt comprise and are selected from the group of being made up of following material: Nitinol, rustless steel shape-memory material, metal, synthetic Biostatic polymer, natural polymer and inorganic material.In embodiments, Biostatic polymer comprises and is selected from the group of being made up of following material: polyolefin, polyurethane, fluorinated polyolefin, chloridized polyolefin, polyamide, acrylate polymer, acrylamide polymer, polyvinyl, polyacetals, Merlon, polyethers, polyester, aromatic polyester, polysulfones and silicone rubber.

In embodiments, natural polymer comprises and is selected from the group of being made up of following material: polyolefin, polyurethane, Mai La, polysiloxanes and fluorinated polyolefin.

In embodiments, the cover of braiding, compression sheath, mandrel, buffer element, retainer belt and woven belt comprise having the material that is selected from the group of being made up of following character: flexible, flexible, plasticity and rigidity.

What reckon with is that during being derived from the application's term of a patent, many relevant support casings and/or support casing material will be developed, and the scope of term stent cover is intended to comprise all new techniques such, supposition.

As used herein, term " about " is meant ± 10%.

Term " comprises (comprises) ", " comprising (comprising) ", " comprising (includes) ", " comprising (including) ", " having " and their variant are meant " including but not limited to ".This term contain term " by ... form " with term " basically by ... composition ".

Phrase " basically by ... form " be meant that compositions or method can comprise other composition and/or step, but only when this other composition and/or step do not change basic and characteristic novelty of desired compositions or method in fact.

Only if clearly explanation is arranged in the context in addition, " (a) " of the employed singulative of this paper, " one (an) " and " being somebody's turn to do (the) " comprise a plurality of indication things.For example, term " chemical compound " or " at least one chemical compound " can comprise multiple chemical compound, comprise its mixture.

Run through the application, the form that various embodiments of the present invention can scope proposes.Should be appreciated that with the description of range format just for ease with succinct, and should not be understood that hard limit the scope of the invention.Therefore, the description of scope should be considered to disclose particularly the individual number in all possible subrange and this scope.For example, the range describe such as from 1 to 6 should be considered to disclose particularly the subrange such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., and the indivedual numerals in this scope, and for example 1,2,3,4,5 and 6.No matter how many scope width is, this all is suitable for.

When this paper points out digital scope at every turn, mean and comprise any numeral (decimal or integer) of enumerating in the pointed scope.First points out that numeral points out numeral and " scope/scope from " first points out that second of numeral " extremely " point out numeral in the interchangeable use of this paper with second phrase " scope/scope between ", and means and comprise first and second pointed digital and therebetween all decimals and integer number.

As used herein; Term " method " refers to be used to accomplish mode, means, technology and the step of given task; It includes but not limited to chemistry, pharmacology, biology, biochemistry and known those modes of medical domain professional, means, technology and step, those modes, means, technology and the step perhaps easily developed by known way, means, technology and step by such professional.

As used herein, term " treatment " comprises elimination, significantly suppresses, slows down or reverses the progress of the patient's condition, significantly improves the clinical or aesthstic symptom of the patient's condition or significantly prevent the appearance of the clinical or aesthstic symptom of the patient's condition.

Should be understood that for the sake of clarity some characteristic of the present invention described in the context of indivedual embodiments also can make up and provide in single embodiment.On the contrary, for the sake of brevity, each characteristic of the present invention described in the context of single embodiment also can individually or with any suitable sub-assembly or as the embodiment that is fit to any other description of the present invention provide.Some characteristic described in the context of each embodiment should not be considered to the essential feature of those embodiments, is inoperative only if there are not those key element embodiments.

Result of the test:

The present inventor finds, embodiment of the present invention potentialization of the support casing of ultimate fibre braiding provide surpass through above-mentioned braiding, knitting, circumvolution, interweave, electric spinning and/or the possible advantage that the porous mould immersed the made support casing of the technology of one or more reagent; Above-mentioned technology causes the cover of big volume usually, and this makes the narrow blood vessel difficulty of operation, if not impossible words.

The present inventor also finds, embodiment of the present invention not only provide and seem the thin cover of maneuverable ultimate fibre braiding, and prevents loose ends along any position cutting of material the time, impels this material to form " reeling off raw silk from cocoons ".

Reeling off raw silk from cocoons in the support casing causes serious problems, and the support mesh is outstanding to enter into the support chamber because the fiber in reeling off raw silk from cocoons passes, and causes potential blood flow retardance.What is worse, the fiber through the support chamber can produce the turbulent flow of not expecting and/or form thrombosis, thereby makes the whole intention failure of support.

In addition, embodiment of the present invention have demonstrated the sth. made by twisting of the ring that prevents the end portion on the nylon of ultimate fibre braiding and have opened, thereby further prevent to reel off raw silk from cocoons.

Except that the above, the present inventor finds, comprises embodiment of the present invention of the support casing that is connected to support movably; (for example United States Patent (USP) the 6th, 712, No. 842 than unfolded support casing before introducing support; Gifford etc., its content is incorporated this paper into through whole introducing modes) potentially, launch more easily possibly, before this is introducing support in the unfolded support casing; The accurate arrangement of the support of required contraction and the cover of expansion is difficult, is the step of not expecting therefore.

In addition, the present inventor finds that embodiment of the present invention can have the advantage above the outside support cover; Said outside support cover has the flare factor similar with support, and (for example United States Patent (USP) the 6th, 794, No. 485; Shalaby, its content is incorporated this paper into through whole introducing modes); Wherein, because the outside support cover shrinks with support during radial dilatation, so this cover can not cushion the above-mentioned shearing force of narrow blood vessel effectively.

Claims

1. assembly that is used to open lumen of vessels, it comprises:

A) expansible support radially, it is provided to open lumen of vessels, and said radially expansible support comprises curved wall, and said curved wall has portions of proximal, distal part and is connected the chamber of said portions of proximal and said distal part;

B) cover of braiding, it comprises the ring of a plurality of interconnection, the cover of said braiding also comprises basically the tubular wall around the outer surface of said radially expansible support; With

C) at least one retainer belt, it passes the ring of at least one braiding in the ring of said a plurality of interconnection slidably,

Wherein, Said at least one retainer belt comprises at least one circumferential part; Said at least one circumferential part is circumferentially around passing through said radially expansible support; And said at least one retainer belt comprises the retainer belt part that at least one is folding, and said at least one folding retainer belt partly extends in the said chamber of said radially expansible support.

2. assembly as claimed in claim 1, wherein, at least a portion of said lumen of vessels is narrow.

3. assembly as claimed in claim 2, wherein, said lumen of vessels comprises arterial lumen.

4. assembly as claimed in claim 1, wherein, at least a portion of the cover of said braiding is woven by ultimate fibre.

5. assembly as claimed in claim 1, wherein, at least a portion of the cover of said braiding is to be woven by the ultimate fibre that contains multifilament.

6. assembly as claimed in claim 1, wherein, when expansible support was in collapsed configuration, said at least one folding retainer belt part operationally was associated with the interior section of the said curved wall of said radially expansible support said radially.

7. assembly as claimed in claim 6, wherein, said support comprises the self expandable support.

8. assembly as claimed in claim 7; Wherein, Said assembly comprises conduit, and the part of said conduit is arranged along the said chamber of said self expandable support, so that folding retainer belt partly is crushed between the said part of said curved wall and said conduit of said self expandable support.

9. assembly as claimed in claim 8, it is configured to so that when the cover expansion of said braiding, the part of said at least one folding retainer belt part is pulled to break away from and operationally is associated with the said of said interior section of said curved wall.

10. assembly as claimed in claim 8, wherein, after the expansion of the cover of said braiding, said at least one folding retainer belt part is circumferentially around at least a portion of said self expandable support.

11. assembly as claimed in claim 6; Wherein, Said assembly comprises the ductus bursae with inflatable tip; Said ductus bursae is arranged along the said chamber of said radially expansible support basically, so that in a single day expand, said inflatable tip just makes said radially expansible support radially outward expand.

12. assembly as claimed in claim 11; It is configured to so that said radially when expansible support is in collapsed configuration, and said ductus bursae is provided to press said at least one folding retainer belt part to the said interior section of the said curved wall of said radially expansible support.

13. assembly as claimed in claim 12, it is configured to so that when the cover expansion of said braiding, the part of said at least one folding retainer belt part is pulled to break away from and operationally is associated with the said of said interior section of said curved wall.

14. assembly as claimed in claim 12, wherein after the expansion of the cover of said braiding, said at least one folding retainer belt part is circumferentially around at least a portion of said radially expansible support.

15. assembly as claimed in claim 1, wherein, at least a portion of said at least one retainer belt comprises elastomeric material.

16. assembly as claimed in claim 1, wherein, said at least one retainer belt passes at least one in the ring of said a plurality of interconnection in the proximal portion of the cover of said braiding.

17. assembly as claimed in claim 1, wherein, said at least one retainer belt passes at least one in the ring of said a plurality of interconnection in the extremity office of the cover of said braiding.

18. assembly as claimed in claim 1, wherein, the midway of said at least one retainer belt between the distal part of the cover of the portions of proximal of the cover of said braiding and said braiding passed at least one in the ring of said a plurality of interconnection.

19. assembly as claimed in claim 1, wherein, said at least one retainer belt comprises:

A) nearside retainer belt part;

B) distally retainer belt part;

C) therebetween center retainer belt part;

D) said at least one retainer belt portions of proximal, it is connected to the cover portions of proximal of said braiding; And

E) said at least one retainer belt distal part, it is connected to the cover distal part of said braiding.

20. assembly as claimed in claim 19, wherein, said at least one folding retainer belt part is by the part location of the retainer belt part along said center.

21. assembly as claimed in claim 20; It comprises at least one limiter; Said at least one limiter operationally is associated with said at least one folding retainer belt part; Wherein, at least one fold in said at least one folding retainer belt part keeps through said at least one limiter.

22. assembly as claimed in claim 21, wherein, said at least one limiter is slidingly attached to said at least one folding retainer belt part.

23. assembly as claimed in claim 21, wherein, said at least one limiter is selected from the group of the limiter of being made up of binding agent, band, ring, bail and suture.

24. assembly as claimed in claim 21, it is configured to so that when said radially expansible support is expanded, and said at least one folding retainer belt partly is pulled to break away from and operationally is associated with the said of said at least one limiter.

25. assembly as claimed in claim 19, it is configured to so that said radially when expansible support is in expanded configuration, and said retainer belt forms basically the shape of single-screw basically around the cover of said braiding.

26. assembly as claimed in claim 19, wherein, at least a portion of said at least one retainer belt comprises elastomeric material.

27. assembly as claimed in claim 19; It comprises the ductus bursae with inflatable tip; Said ductus bursae operationally is associated with the said chamber of said radially expansible support, so that in a single day expand, said inflatable tip just makes said radially expansible support radially outward expand.

28. an assembly that is used to open lumen of vessels, it comprises:

B) cover, it comprises tubular wall, said tubular wall is basically around the outer surface of said radially expansible support; With

C) at least one retainer belt, it comprises at least two parts:

At least one first, it passes at least a portion of the said tubular wall of said cover slidably; With

At least one second portion, it comprises the retainer belt part that at least one is folding, said at least one folding retainer belt extends partially in the said chamber of said radially expansible support.

29. assembly as claimed in claim 28, wherein, at least a portion of said lumen of vessels is narrow.

30. assembly as claimed in claim 29, wherein, said lumen of vessels comprises arterial lumen.

31. assembly as claimed in claim 28, wherein, said at least one retainer belt comprises at least one circumferential part, and said at least one circumferential part is circumferentially around passing through said radially expansible support.

32. assembly as claimed in claim 28, wherein, when expansible support was in collapsed configuration, said at least one folding retainer belt part operationally was associated with the interior section of the said curved wall of said radially expansible support said radially.

33. assembly as claimed in claim 32, wherein, said support comprises the self expandable support.

34. assembly as claimed in claim 33; Wherein, Said assembly comprises conduit, and the part of said conduit is arranged along the said chamber of said self expandable support, so that folding retainer belt partly is crushed between the said part of said curved wall and said conduit of said self expandable support.

35. assembly as claimed in claim 34, it is configured to so that when said cover is expanded, and the part of said at least one folding retainer belt part is pulled to break away from and operationally is associated with the said of said interior section of said curved wall.

36. assembly as claimed in claim 34, wherein, after the expansion of said cover, said at least one folding retainer belt part is circumferentially around at least a portion of said self expandable support.

37. assembly as claimed in claim 32; Wherein, Said assembly comprises the ductus bursae with inflatable tip; Said ductus bursae is arranged along the said chamber of said radially expansible support basically, so that in a single day expand, said inflatable tip just makes said radially expansible support radially outward expand.

38. assembly as claimed in claim 37; It is configured to so that said radially when expansible support is in collapsed configuration, and said ductus bursae is provided to press said at least one folding retainer belt part to the said interior section of the said curved wall of said radially expansible support.

39. assembly as claimed in claim 38, it is configured to so that when said cover is expanded, and the part of said at least one folding retainer belt part is pulled to break away from and operationally is associated with the said of said interior section of said curved wall.

40. assembly as claimed in claim 38, wherein, after the expansion of said cover, said at least one folding retainer belt part is circumferentially around at least a portion of said radially expansible support.

41. assembly as claimed in claim 28; Wherein, the said cover of said support comprises by the made material of the technology that is selected from the group of being made up of following technology: interweave knitting, double rib is knitting, weave, interweave and/or the porous mould is immersed one or more reagent.

42. assembly as claimed in claim 28, wherein, the said cover of said support comprises elastomeric material.

43. assembly as claimed in claim 42, wherein, said elastomeric material comprises rubber.