CN107405208A - Delivery apparatus and delivering method - Google Patents

Delivery apparatus and delivering method Download PDF

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Publication number
CN107405208A
CN107405208A CN201680004913.8A CN201680004913A CN107405208A CN 107405208 A CN107405208 A CN 107405208A CN 201680004913 A CN201680004913 A CN 201680004913A CN 107405208 A CN107405208 A CN 107405208A
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CN
China
Prior art keywords
expansion
silk
delivery apparatus
platform
delivery
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.)
Granted
Application number
CN201680004913.8A
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Chinese (zh)
Other versions
CN107405208B (en
Inventor
迈克尔·隆戈
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Innovasc LLC
Intact Vascular LLC
Original Assignee
Innovasc LLC
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Priority claimed from US15/000,437 external-priority patent/US9433520B2/en
Application filed by Innovasc LLC filed Critical Innovasc LLC
Priority to CN202010834309.6A priority Critical patent/CN112120839A/en
Publication of CN107405208A publication Critical patent/CN107405208A/en
Application granted granted Critical
Publication of CN107405208B publication Critical patent/CN107405208B/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958Inflatable balloons for placing stents or stent-grafts
    • 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/826Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents more than one stent being applied sequentially
    • 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A61F2002/9665Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod with additional retaining means

Abstract

Delivery apparatus can provide the delivering successively of the multiple intracavitary units or nail that are maintained at confined state on delivery apparatus.Delivery platform on the delivery apparatus can be such that nail is maintained at by compression position, and be positioned in annular and promote between, and it can also be radiopaque mark that the annular, which promotes band,.The annular promotes band to be made up of silk or material components to improve flexibility while keep radiopacity.Extension fixture after expansion can be included.Extension fixture can be multiple expansion silk, bellows or sacculus after the expansion.Nail method of deploying may include to allow self expandable to follow closely expansion, by extension fixture after the expansion in nail alignment below, and make after the expansion extension fixture radial dilatation to be pushed out in described nail on.

Description

Delivery apparatus and delivering method
Background
Technical field
There is disclosed herein delivery apparatus and delivering method.Reference delivers multiple intracavitary units from delivery apparatus successively (intraluminal device) describes some embodiments.The delivery apparatus and method can be used for treatment artery athero- The operation of hardening obliteran (atherosclerotic occlusive disease), but it is not limited to these behaviour Make.
Background technology
A variety of wherein place the device of such as support (stent) in vivo to produce or maintain the medical shape of passage be present Condition and operation.In the presence of a variety of supports for various purposes, from distensible coronary stent, intravascular stent and bile duct branch Frame is to for allowing to urinate the plastic stent flowed between kidney and bladder.
Support is generally placed on after the medical care precess of such as balloon angioplasty (balloon angioplasty) In vascular system.Balloon angioplasty is generally used for treating atherosclerotic obliteran.Atherosclerotic Obliteran is palsy in the U.S. and industrialized country, heart attack, loss of limb (limb loss) and the primary original of death Cause.Atherosclerotic plaque forms hard formation along arterial wall, and it is broken to include calcium, cholesterol, the thrombus of compacting and cell Piece.With the progress of atherosclerosis, it is intended to which the blood supply by particular blood vessel is reduced due to seclusion Or even it is prevented from.Clinically one of most widely used method of significant atherosclerotic plaque is balloon for treatment Plasty, support can be carried out after this and is inserted.
Summary of the invention
It is currently available that support and stent delivery system have many limitations and shortcoming.For improving intracavitary unit and correlation There is lasting demand for delivery apparatus.
According to some embodiments, delivery apparatus can provide into is maintained at delivering dress for delivering successively with confined state The multiple intracavitary units (for example, support, nail (tack), bail (staple) etc.) put.For the purpose of present disclosure, word One kind in many intracavitary units that language nail can will deploy for description from delivery apparatus.The delivery apparatus can include multiple pass Platform is sent, the delivery platform is configured to make nail be maintained at the position compressed on delivery apparatus, and with unique shape Shape, such as non-constant external diameter, hourglass shape, the near-end half portion being tapered, ridge, pit etc..This unique shape can dispose Between annular promotes band, it can also be radiopaque mark (radiopaque marker) that the annular, which promotes band,.
In some embodiments, unique shape is by having the sleeve pipe of the flexible material of the unique shape around harder interior axle (sleeve) provide.In addition, annular promotes band (pusher band) can be by silk (wire) or material components (sections of Material) it is made to improve flexibility while keep radiopacity.
Nail method of deploying may include before expansion by external jacket (outer sheath) radiopaque mark with Nail alignment to be deployed.
The method with alignment and intracavitary unit or nail delivering can be marked.Methods described may include:There to be multiple places Area for treatment is advanced into the delivery apparatus of the nail of confined state;Each nail is comprising multiple pillars (strut) and is placed in nail Central area in radiopaque mark, each nail is identical size and radiopaque mark is placed in same position; The delivery apparatus includes the inner core (inner core) with multiple delivery platforms, and each delivery platform has in multiple nails One, and the external jacket of covering inner core and delivery platform, the external jacket is with impermeable from what is distally proximally disposed Radiographic marker band;External jacket is recalled until that the radiopaque on external jacket marks band to nail on to be delivered first is impermeable Radiographic marker aligns;Release follow closely before by the two radiopaques mark with area for treatment (such as tissue to be treated peel off Body (tissue dissection) or focus) alignment;Then external jacket is recalled to discharge nail.
In some embodiments, delivery apparatus can include interior axle, delivery platform and external jacket.Delivery platform can include Around a pair of endless belts of interior axle and sleeve pipe, two endless belts are respectively provided with first external diameter.Sleeve pipe is securable to interior axle and disposed Between endless belt.The hardness of sleeve pipe can be less than interior axle, and most preferably be also less than this to endless belt.Sleeve pipe, which can also have, to be less than The non-constant external diameter of the first external diameter of endless belt.Delivery platform can be configured to receiving and be used to be deployed into blood vessel from delivery apparatus (vessel) intracavitary unit in, and it is contained in the intracavitary unit between endless belt and on sleeve pipe.External jacket can pacify Put in interior axle and delivery platform and can be slided in interior axle and delivery platform, external jacket has the exhibition of covering delivery platform Open front position and at least one delivering position recalled external jacket and make at least one endless belt and sleeve pipe exposure of delivery platform Put.
According to some embodiments, multiple other delivery platforms can be included and be used to deliver multiple intracavitary units successively.Often Individual other delivery platform can include other sleeve pipe and other endless belt.Each endless belt can have certain radius in near-end And/or include radiopaque spiral winding (helical coil).Radiopaque spiral winding can be encapsulated in hardness In polymer higher than the polymer for forming described sleeve pipe.
Sleeve pipe can include any number of different shape and size, and can include ridge, point, pit etc..
In some embodiments, delivery apparatus can include interior axle, and the interior axle has precentrum in distal tip (nose cone);Delivery platform;And external jacket.Delivery platform can include a pair of endless belts for being fixed on interior axle, two rings Shape band is respectively provided with first external diameter;And include the sleeve pipe for being fixed on interior axle and being placed between endless belt.The hardness of sleeve pipe can Less than interior axle, and this is optionally also less than to endless belt.Sleeve pipe can also be constant outer with the first constant outer diameter portion and second Path portion, the external diameter of second constant outer diameter portion are more than the first constant outer diameter portion but are less than outside the first of endless belt Footpath, and the axial length of second constant outer diameter portion is shorter than the first constant outer diameter portion, described sleeve pipe also have the The smooth transition that is tapered between one constant outer diameter portion and the second constant outer diameter portion.Delivery platform can be configured to receiving For the intracavitary unit being deployed into from delivery apparatus in blood vessel, and it is configured to be contained in the chamber between endless belt and on sleeve pipe Interior device.External jacket can be placed on interior axle and delivery platform and can slide on.External jacket can be passed with covering The expansion front position and at least one external jacket of recalling for sending platform make at least one endless belt and the sleeve pipe exposure of delivery platform Delivery location.
In some embodiments, delivery apparatus can include interior axle, distal annular rim band, proximal annular rim band, delivery platform, outer Expanding unit (post dilation deployment device) after portion's sheath and expansion.Distal annular rim band and proximal annular rim Band can surround and be fixed on interior axle.Interior axle can have the first diameter, and distal annular rim band and proximal annular rim band can have and be more than The Second bobbin diameter of (interior axle) first diameter.Delivery platform can be limited by the near-end of distal annular rim band and the distal end of proximal annular rim band It is fixed.Delivery platform can be configured to accommodate be used for from delivery apparatus be deployed into blood vessel distal annular rim band and proximal annular rim band it Between and around interior axle self expandable intracavitary unit.External jacket can be placed on interior axle and delivery platform and can be slided thereon It is dynamic.External jacket can have covering delivery platform expansion front position and it is at least one recall external jacket make delivery platform with And in distal annular rim band and proximal annular rim band at least one exposure delivery location.Expanding unit can include expansion platform after expansion With multiple expansion silks (expansion filament).Expansion platform can be fixed relative to interior axle.The multiple expansion silk can enclose It is radially spaced around interior axle.In addition, each expansion silk in multiple expansion silks can have the end relative to expansion platform to fix First end.The multiple expansion silk can be with the pre-activated position (pre-actuated with diameter before expansion Position) and be more than expansion before diameter deployment diameter actuated position.Expanding unit can be configured to certainly after expansion The inner surface for expanding the backward self expandable intracavitary unit of intracavitary unit expansion applies radial load, is existed with improving self expandable intracavitary unit At least one of in endovascular expansion and (seating) in place of self expandable intracavitary unit in the blood vessels.
Delivery apparatus can include expanding unit after interior axle, delivery platform, external jacket and expansion.Interior axle can be in distal tip It is upper that there is precentrum.Delivery platform can be fixed on the appropriate location in interior axle relative to precentrum.In addition, delivery platform can include It is fixed on a pair of the endless belts and center section of interior axle.Two endless belts can have first external diameter, and center section can have There is second external diameter.Second bobbin diameter is smaller than first external diameter.Delivery platform can be configured to receiving and be used to be deployed into blood from delivery apparatus Intracavitary unit in pipe.More specifically, delivery platform can be configured to the intracavitary dress being contained between endless belt and in interior axle Put.External jacket can be placed on interior axle and delivery platform and can slide on.External jacket can have covering delivering flat The expansion front position of platform and it is at least one recall external jacket make delivery platform at least one endless belt and sleeve pipe exposure Delivery location.Expanding unit can be placed between precentrum and delivery platform after expansion, and can include multiple expansion silks.Expansion It is outside to be produced on the inner surface of intracavitary unit after being discharged in intracavitary unit that silk can be configured to radial dilatation after actuation Radial load.
Intracavitary unit method of deploying may include one or more following steps.By with multiple in confined state The delivery apparatus of intracavitary unit is advanced into area for treatment.Multiple intracavitary units can each include multiple pillars and be placed in intracavitary dress Radiopaque mark in the central area put.Multiple intracavitary units can be each identical size and radiopaque marks It is placed in same position.Delivery apparatus can include the interior axle with multiple delivery platforms, each intracavitary in multiple intracavitary units Device is placed in each delivery platform in multiple delivery platforms;And the external jacket of covering interior axle and multiple delivery platforms, There is the external jacket radiopaque proximally disposed from the distal end of external jacket to mark band.External jacket is recalled until outer Radiopaque mark band on portion's sheath marks with the radiopaque on the first intracavitary unit to be delivered in multiple intracavitary units Alignment.Before the first intracavitary unit is discharged, the radiopaque of alignment is marked into band and radiopaque mark and area for treatment pair Together.External jacket is recalled to discharge the first intracavitary unit.External jacket is recalled until the radiopaque on external jacket marks band With the radiopaque label alignment on the second intracavitary unit to be delivered in multiple intracavitary units.
In some embodiments of methods described, the radiopaque of alignment is marked into band and radiopaque mark and treatment Region alignment may include in marking the radiopaque of alignment before discharging the first intracavitary unit band and radiopaque mark fixed The heart is in tissue incrustate.In some embodiments of methods described, external jacket is recalled until not transmiting on external jacket Wire tag band may include to recall outside with the radiopaque label alignment on the first intracavitary unit to be delivered in multiple intracavitary units Portion's sheath aligns until the distalmost end of external jacket with the distalmost end of the first intracavitary unit.In some embodiments of methods described In, external jacket is recalled until the radiopaque mark band on external jacket and the first intracavitary to be delivered in multiple intracavitary units Radiopaque label alignment on device may include to recall external jacket until radiopaque mark band is placed in the first intracavitary dress The middle part put.In some embodiments of methods described, the first intracavitary unit can have the single post of radiopaque mark, and And external jacket is recalled until the radiopaque mark band on external jacket and the first intracavitary to be delivered in multiple intracavitary units Radiopaque label alignment on device may include to recall external jacket until radiopaque mark band is around radiolabeled Single post.
Intracavitary unit method of deploying may include the delivery apparatus with the intracavitary unit in confined state being advanced to Target volume (target volume).Delivery apparatus can include expanding unit after interior axle, delivery platform, external jacket and expansion.It is interior Axle can have the first diameter.Delivery platform can have proximally and distally endless belt, and it each has straight more than (interior axle) first The Second bobbin diameter in footpath.Delivery platform can be configured to accommodate be used for from delivery apparatus be deployed into volume between endless belt and Around the intracavitary unit of interior axle.External jacket can surround interior axle and delivery platform is disposed and can slid on.External jacket The expanded position that can have the expansion front position of covering delivery platform and expose delivery platform.Expanding unit can include after expansion Multiple expansion silks, the expansion silk be configured to start deploy after after extension fixture radial dilatation with intracavitary unit release and Outwardly radial power is produced after expansion on the inner surface of intracavitary unit.Intracavitary unit method of deploying may also include:Recall outer Portion's sheath is to discharge intracavitary unit;Expand intracavitary unit;Mobile delivery apparatus is with by least a portion of extension fixture after expansion It is placed in the intracavitary unit of expansion;And start expansion after extension fixture so that expansion after extension fixture at least a portion footpath Outwardly radial power is produced to expansion and on the inner surface of expansion intracavitary unit.Expansion step may include to allow intracavitary unit One kind in expansion and on one's own initiative expansion intracavitary unit.
In some embodiments, delivery apparatus includes interior axle, distal annular rim band and proximal annular rim band, delivery platform, outer Expanding unit after portion's sheath and expansion.Distal annular rim band and proximal annular rim band are securable to interior axle.Delivery platform can be in distal loop Between shape band and proximal annular rim band.Delivery platform can be configured to the self expandable chamber for accommodating and being used for being deployed into from delivery apparatus in blood vessel Interior device.External jacket can be slided in interior axle and delivery platform.External jacket can have the exhibition of covering delivery platform Open front position.External jacket can have it is at least one make it is at least one in delivery platform and distal annular rim band and proximal annular rim band Exposed delivery location.Expanding unit can include expansion platform, sacculus and at least one expansion fluid cavity after expansion.Deploy platform It can be fixed relative to interior axle.Sacculus can be fixed relative to the longitudinal axis of expansion platform.Sacculus can be with the cause with diameter before expansion Dynamic front position and the actuated position with more than the deployment diameter of diameter before expansion.At least one expansion fluid cavity can be with ball Capsule is in fluid communication and extended along at least a portion of interior axle.Expanding unit can be configured in self expandable intracavitary unit after expansion The inner surface of the backward self expandable intracavitary unit of expansion applies radial load, to improve the expansion of self expandable intracavitary unit in the blood vessels With in self expandable intracavitary unit in the blood vessels in place at least one of.At least one expansion chamber may be housed in the wall of interior axle It is interior.Delivery apparatus can also include the tubulose axle (tubular shaft) of at least a portion length around interior axle, and in tubulose Space is produced between axle and at least a portion length of interior axle.The inner surface of tubulose axle and the outer surface of interior axle can limit it is described extremely A few expansion chamber.The near-end of sacculus is securable to tubulose axle, and the distal end of sacculus is securable to interior axle.
Brief description
For illustrative purposes, multiple embodiments are shown in the drawings, and should not be in any way by it It is construed as limiting the scope of the invention, in the accompanying drawings, identical reference as one man represents corresponding in similar embodiment Feature.
Fig. 1 is the side view of the delivery apparatus shortened for ease of illustration.
Fig. 2 shows the figure of the distal end for the delivery apparatus that external jacket is recalled.
Fig. 3 shows an embodiment of intracavitary unit or nail.
Fig. 3 A show the flattened section (flattened section) of Fig. 3 nail.
Fig. 4 shows the detailed view of the distal end for the delivery apparatus that external jacket is partly recalled.
Fig. 5 is the section of the delivery apparatus for an embodiment for showing delivery platform.
Fig. 6 A to 6E show multiple embodiments with delivery platform of different shapes.
Fig. 7 A to 7C show some steps of method of deploying.
Fig. 8 A to 8C are with extension fixture (post deployment after the expansion comprising multiple expansion silks Dialation device) delivery apparatus distal end different views.
Fig. 8 D to 8G show the step in the method using extension fixture after the expansion for including multiple expansion silks.
Fig. 9 A to 9B show the section of the different interior axles suitable for accommodating multiple expansion silks.
Figure 10 A to 10C are the delivery apparatus with extension fixture after the expansion comprising sliding sleeve and multiple expansion silks The different views of distal end.
Figure 10 D to 10F are shown using in the method for extension fixture after the expansion comprising sliding sleeve and multiple expansion silks The step of.
Figure 11 A to 11C are the distal ends with the delivery apparatus of extension fixture after the expansion for including sliding sleeve and bellows Different views.
Figure 11 D to 11F show the step in the method using extension fixture after the expansion for including sliding sleeve and bellows Suddenly.
Figure 12 A to 12C are that the difference with the distal end of the delivery apparatus of extension fixture after the expansion comprising inner core sacculus regards Figure.
Figure 12 D to 12F show the step in the method using extension fixture after the expansion comprising inner core sacculus.
Figure 13 A to 13B show the section with the interior axle for being suitable to the fluid cavity to inner core sacculus trandfer fluid.
Figure 14 A to 14B show for capture and limit expansion after inner core sacculus taenidium system.
Detailed description of the invention
Delivery apparatus 10 can be used as treating a part for the operation of atherosclerotic obliteran.Delivery apparatus can For one or more intracavitary units 2 (such as nail) to be delivered into Plaques form position.The nail position can be made stable and/ Or patch fragment is set to be held away from blood flow path.Although it should be appreciated that delivery apparatus described herein and method referring especially to Vascular procedure describes, but it can also be used for the treatment at other positions of body.
A figures 1 and 2 show that embodiment available for the delivery apparatus 10 for delivering multiple intracavitary units 2 successively. Delivery apparatus 10 can be used for the operation for the treatment of atherosclerotic obliteran, but it is not limited to these operations.
Fig. 1 delivery apparatus 10 shortened for the ease of illustration is highlighted distal end 4 and near-end 6.Near-end 6 can Gripped during medical care precess by doctor or other medical professionals.It is used to control one or more intracavitary units or nail 2 delivering.Fig. 2 shows the distal end 4 with the individual intracavitary unit 2 in six (6), and each intracavitary unit 2 is placed in special delivering and put down At platform 8.Compare Fig. 1 and Fig. 2, it can be seen that external jacket 12 is from distally recalling in fig. 2.This makes delivery platform 8 and each From intracavitary unit 2 appear.Intracavitary unit 2 be preferably can self expandable, and shown at it by compression position, to represent it such as What is assemblied in delivery platform.Typical in use, when in the position, external jacket 12 will cover intracavitary unit 2.As incited somebody to action It is discussed more fully below, external jacket 12 can be recalled with system mode with desired treatment position One step development one Individual intracavitary unit 2.
Relatively small intracavitary unit 2 (such as with only one row (Fig. 3 and 3A) or two column units (cell)) can deliver Accurate treatment position and it is properly spaced without overlapping.Fig. 3 A show the flattened section of Fig. 3 nail.It is as can be seen that single Column unit 14 by two annular concentrics of wavy pillar 16 for being connected by bridge member 18 into.Bridge member 18 has a pair of anchors Determine part 20 and radiopaque mark 22.Intracavitary unit can be also made up of two or more units, or as an alternative by this Known other structures are formed in field.Multiple small intracavitary units 2 can be used for treating one or more focuses.This can make in vivo The amount of foreign substance minimizes, while provides required confining force.In the following related application of applicant in more detail Describe multiple embodiments of intracavitary unit and delivery apparatus:That is submitted on July 8th, 2011 is used as US 2012/ Patent application No.13/179 disclosed in 0035705 (IVAS.002P4), 458, and in the conduct submitted on January 24 in 2013 Patent application No.13/749 disclosed in US 2013/0144375 (IVAS.002P6), 643, the two is incorporated by reference into this Text, and as the part of this specification.
It should be appreciated that delivery apparatus and method can be additionally used in other intracavitary units 2, including larger device, and it is unlimited In for only having the intracavitary unit 2 of a row or two column units.
Turning now to Fig. 1, the near-end 6 of shown embodiment will now be described.Delivery apparatus 10 can include external jacket 12, near End housing 24 and interior axle 26.External jacket 12 may be configured to polymer extrusion (polymer extrusion) and be embedded in poly- The laminate (laminate) of braided wires (braided wire) in compound extrusion.The quantity of braided wires, braiding can be passed through Pattern controls flexible and rigidity with spacing is woven.In other embodiments, external jacket can be by hypotube (hypotube) (such as metal or plastics hypotube) formation.The flexibility and rigidity of sheath can be (such as coastal by many features The slope and frequency in the helical cut portion of wave duct length) control.External jacket can be additionally included in distal end or close distal end not Radioparent (RO) mark 28.In some embodiments, radiopaque mark 28 can be the endless belt separated with distalmost end.
As indicated, external jacket 12 is braiding axle, and near-end housing 24 is by strain relief member (strain Relief) the 30 bifurcated female Luer (bifurcation luer) for being connected to external jacket.Strain relief member 30, which can use, appoints What form, such as be made up of polyolefin or other similar materials.
Bifurcated female Luer 24 has the principal arm and side arm for accommodating interior axle 26.Bifurcated female Luer may be provided at external jacket Near-end.Side arm, which includes, to be used to rinse out air and improves the irrigation ports of the lubricity in space between sheath and interior axle (flushing port)。
Tuohy borst adapters, haemostatic valve or other sealing devices 32 can be set in the near-end of bifurcated female Luer 24 Or be integrated into bifurcated female Luer 24, to accommodate and seal the near of the space between interior axle 26 and external jacket 12 End.Tuohy borst adapters may also provide locking interface (such as screwed lock) to ensure between external jacket and interior axle Contact.This can allow doctor to be properly positioned distal end without prematurely deploying to follow closely.
Interior axle is shown having proximal luer female connector (proximal luer hub) 34 and expansion reference marker 36.Expansion Reference marker 36 may correspond to delivery platform 8 so that the interval between each expansion reference marker can be with the feature of delivery platform Between interval it is identical.For example, the interval between expansion reference marker can be identical with the distance between delivery platform center.
In some embodiments, distalmost end expansion reference marker or the mark different from remaining expansion reference marker (such as with wider band or different colours) may indicate that initial or home position.For example, the band compared with remaining expansion reference marker Broader expansion reference marker can align with the near-end of bifurcated female Luer 24 or haemostatic valve 32.This can indicate outer protective to doctor Set is in the interior axle 26 that the near-end of precentrum 38 is completely covered.In some embodiments, this alignment is also convertible into outer protective The RO marks 28 put and the RO label alignments on the distal end of interior axle 26.
In some embodiments, one or more expansion reference markers 36 can represent the quantity of nail in system.Therefore, Once releasing nail, expansion reference marker 36 will be capped, and doctor is known that remaining expansion reference marker corresponds to The volume residual of workable nail.In such a embodiment, the near-end of bifurcated female Luer 24 or haemostatic valve 32 can It is advanced to and is located substantially at the center between two reference markers to indicate to deploy.It will also be understood that delivery apparatus can have handle or Trigger assembly, such as the U.S. Provisional Application No.62/109550 (Dkt.No.VAS.025PR) submitted on January 29th, 2015 With United States Patent (USP) No.9, those described in 192,500 (Dkt.No.IVAS.025A), the two is both incorporated herein by reference, And it is considered as the part of this specification.
Referring now to Fig. 4, the detailed view of the distal end 4 of delivery apparatus 10 is shown.The feature of shown embodiment includes Interior axle 26 with distal soft tip 38.Tip 38 can be the precentrum being tapered.Precentrum 38 is used as expansion structure, with Tissue is removed with no damage and helps to guide delivery apparatus to pass through vascular system.Tip 38 itself can be radiopaque, or Person can be incorporated to radiopaque element 27 in tip or nearby.It can be seen that extend to proximal luer female connector 34 through interior axle 26 The guidewire lumen 40 of (Fig. 1).Guidewire lumen 40 is disposed for accommodating and promoting seal wire wherein.
It also show the part of delivery platform 8.Delivery platform 8 is identical in the illustrated embodiment, but other Embodiment can be of different sizes and construct between different delivery platforms.Curling or pressure are shown in delivery platform 8 The nail 2 of contracting.
It can be noted that one or more delivery platforms 8 may be provided at neighbouring in interior axle 26 pass such as in Fig. 2 and Fig. 4 Send the distal end 4 of device 10.Each delivery platform 8 can include the recess 42 for being placed in and extending between a pair of annular promotion bands 44.Fig. 5 Show section of the delivery apparatus at a delivery platform embodiment 8A.In the illustrated embodiment, the first platform 8A Proximal annular rim promotes with 44A the distal annular rim promotion band 44A for the platform 8B (only shown partially) for being also adjacent proximal ends placement.With it is recessed Delivery platform at portion 42 is compared, and annular promotes band 44 to have larger external diameter.In some embodiments, recess can be defined to One or two adjacent annular promotes band or diameter smaller area in-between, and/or other feature in interior axle 26.
It can be radiopaque mark band that one or more annulars, which promote band 44,.For example, it can be set proximally and distally not Radioparent slug band 44, to make the end of platform 8 visible using standard visible technology.Annulet band 44 can use any Suitable form, such as including the one or more in tantalum, iridium and alloy platinum material.In some embodiments, promote band 44 can To be 4mm length, the recess with 6.75mm in-between.6.5mm nail can be disposed between band 44 is promoted.In some embodiment party In case, promotion band can be the 50% to 70% of the size of recess and/or nail.In some embodiments, it is about to promote band 60%.In other embodiments, promote band can be smaller, be the 10% to 20% of the size of recess and/or nail.For compared with Spike, this can be especially true.In some embodiments, at least near-end of band 44 is promoted to have certain radius, to help to drop The possibility of the low nail that expansion is blocked during delivery apparatus is retracted.
Reduce recess and nail between difference in length can improve nail place accuracy, especially for only one row or The nail of two column units.In some embodiments, recess longer than nail can be less than 1,0.5,0.4,0.3,0.25 or 0.2mm.Nail Can be the different size of Arbitrary Digit, such as length is 4,5,6,6.5,8,10 or 12mm.
External jacket 12 can be made up of polyether block amide (PEBA), and it is with thermoplasticity obtained by trade name PEBAX Elastomer (thermoplastic elastomer, TPE).In some embodiments, external jacket 12 can have by polytetrafluoro Relatively thin liner made of ethene (polytetrafluoroethylene, PTFE) (such as TEFLON).Any radiopaque mark Band 28 or other radiopaque materials can be placed between this two layers.In other embodiments, radiopaque mark band 28 Or other radiopaque materials can be embedded in one or more layers of external jacket 12.Radiopaque mark band 28 can be 0.5mm to 5mm is wide and is located at the near-end 0.5mm to 10mm at distalmost end tip 52.In some embodiments, radiopaque mark Remember that band 28 can be that 1mm is wide, and at the nearside 3mm at distalmost end tip 52.
In Fig. 5 section, it can be seen that sleeve pipe 46 is placed between two endless belts 44 around interior axle 26.At some In embodiment, delivery platform 8 can include around axle 26 sleeve pipe 46, its middle sleeve 46 be made up of the material different from axle 26 or With the material character different from axle 26.In some embodiments, sleeve pipe provide with viscosity, grip, floral designs and/or The material of other features, to help to follow closely the appropriate location being maintained in delivery platform.In some embodiments, sleeve pipe can be by PEBA is made.Interior axle according to some embodiments is the composite extrusion made of PTFE/ composite polyimide materials. Sleeve pipe is than interior axle and/or promotes band 44 more soft (hardness is lower).Even if be made up of the material of similar type or this Kind situation.In some embodiments, sleeve pipe can be the material with viscosity, grip, floral designs and/or other features, To help to follow closely to be held in position in when recalling external jacket 12 (such as lengthwise position relative to interior axle).This can be improved Controlled quentity controlled variable during expansion, and reduce nail and projected from delivery platform to distal end and (be referred to as watermelon sowing (watermelon in the industry Seeding possibility)).In some cases, external jacket can be removed partly so as to partially exposed intracavitary unit, This intracavitary unit, which can partly be expanded while be delivered device before complete release, to be firmly held.
The nail 2 that can be sized to cause in delivery platform 8 of sleeve pipe 46 has minimum empty between nail and external jacket Between to without space.In some embodiments, sleeve pipe 46 can be with the co-molded of interior axle 26 or being expressed into interior axle 26.In some implementations In scheme, delivery apparatus 10 may be formed to have the single sleeve pipe 46 extended in the length of interior axle 26.For example, sleeve pipe can be from One delivery platform extends to last delivery platform.Endless belt 44 can surround the different piece of sleeve pipe 46, or it can sleeve 46 encapsulatings.In some embodiments, each delivery platform 8 has the single sleeve pipe 46 being placed in recess 42.Endless belt 44 can be encapsulated by different materials, or can not encapsulate.
From Fig. 5, it will be seen that, sleeve pipe 46 can be cylindrical, wherein being maintained in a part or whole length for sleeve pipe Circular cross-section.In other embodiments, sleeve pipe has unique shape and can include following one or more:Gradually Attenuate (Fig. 6 A to E), hourglass shape (Fig. 6 A), ridge (Fig. 6 B), pit (Fig. 6 C), point (Fig. 6 D), two or more are different Diameter (Fig. 6 E) etc..Such as the feature of ridge, point and pit can be disposed with a variety of different patterns or group.In addition, sleeve pipe (figure 6B to D) or sleeve pipe a part (Fig. 6 E) can along less than whole recess extend.In some embodiments, sleeve pipe or larger outer The length of path portion may correspond to the length of nail.For example, sleeve pipe or larger diameter portion may extend away 3/4, the 2/ of recess and/or nail 3、1/2、2/5、1/3、1/4.In addition, sleeve pipe or compared with large outer-diametric portion length can (such as most proximal end be wavy with wavy rings 16 Ring) B-C post size it is related.For example, it can be along the whole of strut lengths or the wavy ring length of most proximal end, 4/5,3/4,2/3 Or 1/2 extension.The relatively large outer-diametric portion of short sleeve or sleeve pipe preferably extends (Fig. 6 D to E) from the proximate of recess, but Also can at the center of recess, be placed in distal end (Fig. 6 C) or the other positions in recess.
Fig. 6 E sleeve pipe is shown having two different constant outer diameter portions, therebetween with the short portion that is tapered.Set Pipe can be formed by two parts separated being thermally bonded together.Be tapered partly can also be produced by hot adhesion so that two There is smooth transition between individual constant outer diameter portion.As described above, larger constant outer diameter portion is preferably from the near of recess Hold to distal end and extend.As discussed above, can be with or without constant outer diameter should can be along less than whole compared with large outer-diametric portion Individual recess extension.
In some embodiments, interior axle 26 can have the sleeve pipe 46 compared with soft between pushing part 44.It is rollable to follow closely 2 On sleeve pipe 46, and external jacket 12 can be by the nail constraint of curling in position.Between sleeve pipe 46 and external jacket 12 Gap may be such that slight interference fit between the nail 2 of curling and interior external component (interference fit).This light interference Delivery system is allowed to constrain the nail of curling during expansion, until it is almost fully drawn out sheath so that the distal portions " flower of nail Valve " is opened and engages vascular wall, reduces the possibility of jump.
According to some embodiments, interior axle 26 can be combined by polyimides-PEBA and is made, and be covered compared with the PEBA of soft Pipe 46 can hot adhesion between pushing part 44.Follow closely 2 rollable on sleeve pipe 46, and the external jacket 12 of PTFE liners will can be rolled up Bent nail constraint is in position.
Fig. 5 is returned to, shows the feature of some embodiments of radiopaque mark band 44.As already mentioned, sleeve pipe 46 can encapsulate endless belt 44.Or another material can encapsulated metal band to form annulet band 44.Annulet band 44 can It is made up of the block of material of line 48 or more or improves flexibility with slit while keep radiopacity.In some embodiments In, silk can form the spiral winding wound around interior axle 26.
Turning now to Fig. 7 A to 7C, some method of deploying will now be described.It is athero- that delivery apparatus 10 can be used as treatment artery A part for the operation of hardening obliteran.Delivery apparatus can be used for one or more intracavitary units 2 (such as nail) It is delivered to Plaques form position.These nails can make the position stable and/or patch fragment is held away from blood flow path.
Nail preferably can self expandable.Therefore, recall sheath 12 allows nail to be filled by self expandable from delivering so that nail 2 appears Put 10 expansion.Sheath can be recalled with little increment so that the desired locations delivered successively in the blood vessel will be followed closely.In some embodiments In, little increment may correspond to deploy reference marker 36.Expansion reference marker 36 can be spaced the length at least followed closely so that each nail can Deploy immediately, rather than typically gradually discharged compared with long stent.This can allow more accurately to place nail.
Balloon angioplasty is opened in each vescular bed in vivo known in one kind of closing or narrow blood vessel Method.Balloon angioplasty is carried out using balloon angioplasty catheter.Balloon angioplasty catheter is by attached It is connected to the cigar shape of conduit, cylindrical balloon composition.Remotely enter from the opening exposure percutaneously or through artery is caused Balloon angioplasty catheter is positioned in artery by site.Conduit is worn on the silk in guiding catheter path along the inside of blood vessel Cross.The conduit portion for being attached with sacculus is placed on the position for the atherosclerotic plaque for needing to treat.It is expanded to sacculus The size consistent with the green diameter of the prerolandic artery Rolando of generation obliteran.In some cases, sacculus is coated with medicine or life Tetramune is otherwise configured to deliver it to tissue.As the balloons are inflated, patch is destroyed.Formed in patch Parting plane, it is allowed to patch with expansion balloon dilation diameter.As a rule, a part for patch than patch remainder more resistant to Expansion.When this occurs, bigger pressure is pumped into sacculus so that sacculus completely expands to its desired size.Make sacculus Shrink and remove, check again for artery section.The process of balloon angioplasty is the process of uncontrolled plaque rupture.Control It is generally somewhat greater to treat the chamber of the blood vessel at position, but not always and this is unreliable.
By plaque rupture, some caused partings plane can form incrustate under balloon angioplasty.More generally, Artery is left when a part for patch or tissue is lifted, artery is not adhered to completely and can be moveable or loose When, there is incrustate.It is projected into by the patch or tissue of pull out type fracture in flowing stream.It is if complete on blood flow direction Patch or tissue are lifted entirely, can hinder to flow or cause the acute occlusion of blood vessel.Evidence suggests after balloon angioplasty Incrustate must be handled to prevent occlusion and solve Detecting Residual Stenosis.Also evidence suggests in some cases, beneficial The metal holding structure for placing such as support or other intracavitary units, with postangioplasty make artery stay open and/ Or the material of peeling is forced against vascular wall to produce the suitable chamber for blood flow.
A variety of delivering methods and device can be used to deploy the intracavitary unit of such as nail 2, some of them are carried out below Description.For example, nail is delivered in blood vessel using intravascular insert.Delivering dress for the different embodiments of patch nail It can be different or identical to put, and can have the feature for being specially designed for delivering specific nail.Nail and installation manipulation can To design in many ways, it shares following common method:Utilize the expansionary force (such as balloon expandable) and/or ripple of delivery mechanism The expansionary force of shape ring enables the position that nail is moved in blood vessel, then discharges in the blood vessels to expansion state.Follow closely expansion side Method may include to mark the radiopaque on external jacket before expansion aligns with nail to be deployed.
Referring now to Fig. 7 A, the delivery apparatus 10 with the external jacket 12 of state before the first expansion is shown.It is more Individual nail 2 can be maintained in delivery apparatus 10 by external jacket 12 with confined state.In some embodiments, nail 2 is quick Its confined state is frozen in order to be loaded on delivery apparatus.As already described, nail can be in the given length of delivery apparatus Upper extension.
Delivery apparatus can be advanced into therapentic part on seal wire 50 in patient vessel's system.Seal wire 50 is grasped before being Make the identical seal wire used in step, such as disposing the seal wire of angioplasty balloon.Once treatment position is placed in, External jacket 12 can be recalled or is retracted into the second expansion front position (Fig. 7 B).Second expansion front position can be used for adjusting outer protective The position of set is to consider any stretching, distortion etc. that some may be needed to adjust before release is followed closely.Deploy front position second, The distal end 52 of external jacket can be placed in the distal end of nail to be deployed or the slightly distant place of distal end.
According to some embodiments, external jacket 12 can have radiopaque annulet band 28, and nail can also have One or more radiopaque marks 22.Radiopaque mark 22 can surround nail and be disposed with post.From the distal end of nail to not transmiting The distance " L " of wire tag 22 can be identical with the distance of the distal end 52 from external jacket 12 to radiopaque annulet band 28. In some embodiments, the distance is the center to mark 22 and mark band 28.In some embodiments, on external jacket Length " L " is at least equally grown with the length " L " nailed on, if slightly growing.External jacket can not transmit without other Wire tag.In addition, nail can also be without other radiopaques mark or radiopaque mark post.Therefore, external jacket can only have There is a mark band 28 in distal end, the distalmost end 52 of itself and external jacket 12 is spaced at least from the distalmost end of nail 2 to not transmiting The distance of wire tag 22 or radiopaque mark post.In the illustrated embodiment, radiopaque mark 22 or radiopaque mark Post is placed in the centre of device.Radiopaque mark is also placed on the bridge member 18 for the adjacent ring for connecting wavy pillar 16. In some embodiments, radiopaque mark 22 or radiopaque mark post can be with the wavy pillars 16 in distalmost end interval of nail At least one ring.In the illustrated embodiment, radiopaque mark 22 or radiopaque mark post are not following closely 2 distalmost end, and It is to be spaced from.
Following closely and there is corresponding radiopaque mark 22,28 doctor can be allowed to be alignd before expansion is followed closely on external jacket Mark 22,28.In addition, doctor can be by the mark of alignment and desired region alignment to be treated.It is as it will be appreciated, all this right The neat visualization technique that all can be used standard is completed.As already mentioned, it can also be not that the annular in interior axle, which promotes band 44, Radioparent.In some embodiments, promote band 44 can be identical and can under visualization with external jacket Both marks for marking and nailing on show difference.Therefore, doctor can understand all marks where and which is which. For example, band 44 is promoted to be longer than the mark 28 on external jacket and the mark nailed in the axial direction.In addition, the mark on delivery apparatus Note can be band, and the mark nailed on can be a little.
Referring to Fig. 7 B, it can be seen that the mark 22 on the nail of mark 28 and first 2 on external jacket 12 aligns, and protects The distal end of set is placed in the distal end of the first nail.Delivery apparatus can be disposed to be treated relative to focus, such as passed through now Radiopaque mark is centered in desired locations.Then sheath can be recalled so that nail is placed on into desired locations.
In some embodiments, mark band of the delivery apparatus on external jacket can be from distally proximally-nail length At least half disposes, and follows closely the single marking post between having in a device.Method of deploying may include to recall external jacket until outside Sheath and the label alignment nailed on to be delivered, then before release is followed closely by the two marks and focus to be treated (or other Area for treatment) justified, be released through and further recall external jacket to realize.It should be appreciated that promote the mark on band 44 Note can also be used for helping the delivery apparatus that aligns before expansion.
Methods described is repeated to deliver multiple nails (referring to Fig. 7 C, only for reference with the nail shown in confined state). Between nail expansion, delivery apparatus can be moved to entirely different focus or area for treatment, or simply relocate with true The interval protected between the adjacent nail placed.
As discussed previously, in some embodiments, it can occur what is entirely followed closely after delivery apparatus release in nail Place simultaneously.In addition, multiple nails can be placed according to being placed from distal end to near-end in the treatment section of blood vessel as desired.
In some embodiments, expansible nail as shown in figs. 3 and 3a can apply to the lumen of vessels diameter of wide scope The power of relative constancy, so as to allow single delivery catheter that multiple nails are deployed into various sizes of blood vessel.It is desirable that nail can design Into the blood vessel for treatment 2 to 8mm sizes, but it can also deliver the nail of other sizes.It is expected to pass through nail in the range of 3mm expansions The power of blood vessel is applied in 5N or smaller changes.It is more desirable that in the range of 3mm expansions, the power of application will be in 1.5N or smaller Change.
There is a situation where to use the sacculus through drug coat as the alternative by support placement in the blood vessel.Sacculus can Expand narrow in blood vessel, and medicine helps to minimize can cause inflammatory reaction after the expansion of arterial restenosis.Clinical evidence Show, the combination of sacculus and medicine can provide the alternative of implantation conventional bracket, be implanted into classical support and be used to provide in the past Short-term and long-term two kinds of situations of support.Sacculus through drug coat is desired, because no long-term implant is placed on blood vessel In.However, that the expansion through drug coat sacculus can cause damage in the form of organizing incrustate to blood vessel be present, In this case, the valve of tissue or fragment are extended in the chamber of blood vessel.Incrustate may alternatively appear in sacculus area for treatment and control Treat region exterior or near.In these cases, the tissue staple of peeling is leaned against and be helpful on arterial wall.With low outside The nail of power, which is advantageously used for treating support, may be not suitable for or undesirable incrustate.
In some embodiments, catheter placement can set by the accurate of nail after in the blood vessels based on the position of mark Place.Once placement, it can then deploy while conduit is maintained in situ and slowly removes external jacket one or more Individual nail.
In some embodiments, one or more nails can be deployed at the incrustate of tissue.When perform blood vessel into When shape art operates, generally there are one of following three kinds of results:1) optimum, it is not necessary to carry out further support and insert or excessively Processing;2) Detecting Residual Stenosis, it usually needs place support to strut or support blood vessels so that it stays open and not returned to Occlusion before or Partial occlusion state, and 3) organize incrustate.Tissue incrustate can be that blood vessel experience wound is for example dynamic Astillen destroys the situation for causing theca interna to separate.This can be or can not be flowing limitation.One or more nails can have Such tissue incrustate is deployed in sharply.Tingle allows processing to operate the vasculature part handled by balloon angioplasty Subclass, so as to provide the processing treatment that long metallic support need not be implanted on whole angioplasty processing region.It is desirable that One or more nails can be used for the 60% or smaller of the length of processing angioplasty processing region medium vessels.In processing tissue In incrustate, compared with usual available support, have the tingle of single-row (diagram) or biserial unit shown cause it is less Damage and there is shorter recovery time.
After nail is placed, blood vessel structure therein is formed in situ.Original position place can in any suitable blood vessel, such as In any peripheral arterial.The structure is not limited to only two nails.In fact, blood vessel structure therein that can be formed in situ It is middle that multiple at least three intravascular nails are provided.In one embodiment, the length each followed closely under the state that is uncompressed does not surpass Cross about 8mm, e.g., from about 6mm.It is at least one in a kind of structure, such as each nail and adjacent nail interval at least about 4mm, or About 4mm is to 8mm, or about 6mm to 8mm.Although some embodiments have 8mm or smaller length, other embodiment party Case can be with longer, such as up to about 12 or 15mm length.In addition, adjacent nail can be positioned to be separated by closely to 2mm, do not inclining particularly To in the blood vessel of bending or other motions.In some embodiments, delivery apparatus can be pre-loaded with six nails, Mei Geyue 6.5mm is grown, and 15cm focus is up to available for treatment.
Herein in described a variety of delivery apparatus, spacing between controllable implantation nail is to maintain between each nail Setting or minimum range.As can be seen that delivery apparatus and/or nail can include the spy for helping to maintain the desired distance between following closely Sign.Spacing can help ensure that these nails are distributed in desired length between maintaining suitable nail, without being in contact with each other or being gathered in In a certain region of treated blood vessel.This can help to prevent the kink for being wherein disposed with the blood vessel of nail.
Although three pin structure bodies being formed in situ are suitably adapted for some idicatios, there is the intravascular nail of at least five It is (non-Focal that blood vessel structure therein can be advantageous to treatment loosening patch, valnllae vasorum, incrustate or other diseases significantly more extended ).For example, although most of incrustates are Focal (for example, axially short), a series of incrustate, which can be used as, more to be stretched Long disease considers and treatment.
In some cases, the even shorter nail of axial length can be used for the bigger position for the treatment of interval.For example, can be by respectively The disease (tackable malady) of nail can be used with treatment in the blood vessel by being placed from of length no more than about 7mm multiple nails.At least Some nails can be with adjacent nail interval at least about 5mm.In some cases it may be preferred to it can be about that ground can provide between adjacent nail 6mm is to about 10mm gap.
Once placed Vascular implant (such as following closely 2), the area that the incomplete note of implant invests natural vessel wall may be present Domain.This can be due to that luminal wall surface is irregular.The region that the incomplete note of implant invests chamber surface can cause the blood of suboptimum Hemodynamics flow.Therefore, optionally, in order to ensure the complete note of the Vascular implant (for example, nail 2) of expansion is attached, can be inserted into Device is with further expanding nail 2.For example, can introduce foley's tube be used for deploy after expand, be placed in following closely 2, and then expand Gently to force the pillar of nail 2 against cavity wall.
As just discussed, it will be followed closely and expanded using single device (such as original or new angioplasty balloon) To desired expansion state need with delivery apparatus 10 place nail 2, remove delivery apparatus 10, insertion new equipment (for example, newly Sacculus or angioplasty balloon), expansion new equipment shrinks new equipment, and new clothes are removed from vascular system with expanding nail 2 Put.The other conduit, which exchanges, causes operating time and cost more, and produce with the undesirable interaction of implant (such as Displacement) possibility and vascular damaged possibility.
Therefore, the part expanded after the expansion that some embodiments of delivery apparatus 10 include being used to follow closely 2.Multiple embodiment party Case discloses the implant of extension fixture after the expansion comprising a variety of offer integrated form enlarging properties (for example, mechanical expansion feature) Delivery system.The enlarging property can be used for ensuring after self expandable Vascular implant deploys to the optimal implant of intravascular space Grappling and circumferential implant note are attached.The advantages of extension fixture provides after onboard (onboard) expansion may include:Deploy multiple from expansion The conduit for open implant, eliminating needed for the rear expansion of self expandable implant exchanges and the difficulty related to swap operation and wind Danger, reduce or eliminate with consumption additional balloon conduit be used for implant after expand related cost, shortening operate the duration, with And reduce ultimate cost.
Delivery apparatus can be identical with other delivery apparatus discussed herein, wherein with the addition of extension fixture after expansion. Extension fixture can include expansion member and sprawl and control part 1730 after expansion.Expansion member can take various forms, including for example Expand silk 1710,1910, bellows 2010 or inner core sacculus 2110.In some embodiments, expansion member includes removable Framework, wherein one end of the framework is configured to move towards the other end, so that framework is expanded.Framework can be by expansion silk 1710th, 1910 or bellows 2010 and other designs be made.Expansion member can be placed in expansion platform.
Sprawl and control part 1730 can be placed in the near-end of delivery apparatus 10, and can be activated by user to control expansion member The expansion of part.In some embodiments, sprawl and control part 1730 can be trigger member, cable or one or more End.
Extension fixture can include one or more radiopaques and mark after expansion, such as band or ring 1720,1722.One Or more radiopaque mark can extension fixture after deployment one or more ends, center or other positions.One Or more radiopaque mark can also be moved with the expansion of expansion member.In some embodiments, in interior axle most Distal annular rim promotion band 44 can limit the near-end of extension fixture after expansion.Precentrum 38 can limit expansion after extension fixture it is remote End.Because precentrum 38 and promotion both bands 44 can be radiopaque, therefore extension fixture can not include after expansion Any other radiopaque mark.
In general, delivery apparatus 10 can include one or more delivery platforms as described herein, it can pass through The near-end of external jacket 12 slide axially and expose (its can be slid axially as an alternative by the distal end of external jacket 12 and by Covering).Delivery platform is configured to accommodate and keeps one or more intracavitary units (such as self expandable nail 2).Intracavitary unit can Make delivery platform exposure by recalling external jacket 12 to discharge or be deployed in volume (such as blood vessel).Except be configured to keep simultaneously Outside the delivery platform for then discharging one or more (such as multiple) intracavitary units, after delivery apparatus 10 can also include expansion Extension fixture.
As disclosed herein, extension fixture is a part for delivery apparatus 10 after expansion, and its at least a portion can pacify Put in expansion or stretched intracavitary unit (for example, having allowed for the self expandable nail 2 of expansion).Exhibition disclosed herein Diameter before the first expansion substantially the same or close with the diameter of the interior section of delivery apparatus can be had by opening rear extension fixture. It can also have the second deployment diameter more than diameter before the first expansion.Once being placed in intracavitary unit, dress is expanded after expansion Put radially distensible to be pushed out on the inner surface of intracavitary unit.In other words, extension fixture is arranged so as to open up after expansion Open at least a portion of the inner surface of at least a portion contact intracavitary unit of rear extension fixture and to the interior table of intracavitary unit Face applies radial load.By to the inner side of intracavitary unit (that is, at least a portion of the inner surface of intracavitary unit) apply outwards or The power of radial direction, after expansion extension fixture can make intracavitary unit further expand and/or more uniformly in place against accommodate its The surface of volume (for example, blood vessel).After deployment extension fixture it is stretched with intracavitary unit apply outwards/radial load it Afterwards, it can be shunk or be compressed so that it can remove (for example, recalling) without being twined with intracavitary unit from intracavitary unit by lower section Knot.
Delivery apparatus 10 can include extension fixture after only one or multiple expansion.Extension fixture after deploying including only one When, extension fixture can be located between distal end, the first delivery platform and the second delivery platform of the first delivery platform, deliver after expansion Below platform or even in the near-end of all delivery platforms.Delivery apparatus 10 can include extension fixture after more than one expansion, example Such as extension fixture after two, three, four, five or six expansion.When extension fixture after comprising more than one expansion, expansion Afterwards extension fixture can be located at delivery platform proximally and distally, between two or more delivery platforms, or two or more In individual delivery platform.
As described elsewhere herein, delivery apparatus 10 can be in its proximal end operation/actuating, such as recalls external jacket 12 simultaneously And one or more nails 2 of expansion.In substantially the same manner, exhibition disclosed herein can be activated from the near-end of delivery apparatus 10 Open rear extension fixture.So, operator can insert delivery apparatus 10 in volume (such as patient vessel), and delivery apparatus 10 is pushed away Target site is entered, recalls external jacket 12, expansion nail 2, and using extension fixture after expansion, its is all from delivery apparatus 10 Near-end is carried out.
After expansion at least some embodiments of extension fixture include multiple expansion silks 1710 as shown in Fig. 8 A to 10F, 1910.As will be explained in more detail, expansion silk can use many forms, for example, free floating or relative to expansion after The near-end of extension fixture or distal end are fixed.Expanding silk can prebuckling, pre-formed or preform so that circle can be presented in it when expanded Cylindrical shape or other shapes consistent with desired shape of blood vessel.For example, as shown in Figure 8 F, expansion silk 1710 is in each end It is upper that there are two bending sections, to be collectively forming the end cap for being connected to the longitudinal component parallel with the longitudinal axis of interior axle.
When the distal end of extension fixture after relative to expansion is fixed (Fig. 8 A to 8G), expansion silk 1710 can be towards expanding after expansion The distal end for opening device is promoted or extended to distal end.This promotion or extension can make expansion silk be bent outwardly or bend.Expand silk Extra promotion or extension expansion silk can be made further to be bent outwardly or bend.Extension fixture is located at intracavitary unit after expansion When interior, expansion silk can be promoted or extended far enough so that it contacts intracavitary unit and applies outside or radial direction power (as above to it Discussed).The extension fixture (for example, applying radial load on the inner surface of intracavitary unit) after expansion is used, Expand silk regracting.Expansion silk retraction it can be made to lie flat against on delivery apparatus 10 so that delivery apparatus 10 can recall and It will not be stuck on intracavitary unit.
Or expansion silk 1910 can be fixed (Figure 10 A to 10F) relative to the near-end of extension fixture after expansion.When relative to When the near-end of extension fixture is fixed after expansion, expansion silk can be fixed on slidable structure, such as ring 1920 in its distal end.When can slide When dynamic structure slides (draw or traction) towards the near-end of delivery apparatus 10 (also towards the near-end fixing point of expansion silk), make expansion silk It is bent outwardly or bends.The additional proximal of slidable structure, which is slided, makes expansion silk further be bent outwardly or bend.If exhibition Open rear extension fixture to be located in intracavitary unit, then the slidable structure can proximally be slided remote enough so that expansion silk bent outward It is bent with contact intracavitary unit and apply on intracavitary unit outwards or radial direction power (as described above).After expansion is used Extension fixture (for example, applying radial load on the inner surface of intracavitary unit), slidable structure can be promoted to distal end.Will Slidable structure is promoted to distal end makes expansion silk lie flat against on delivery apparatus 10 so that delivery apparatus 10 can recall without It can be stuck on intracavitary unit.Can be only comprising extension fixture after an expansion based on expansion silk.However, it can include more than one (for example, being incorporated to one group of expansion silk in each delivery platform).
In some embodiments, the intracavitary that expansion silk 1910 can be placed in internals, and the distal end of ring 1920 Movement can recall silk 1910.The expanded form of prebuckling or shaping can be then presented further to expand intracavitary unit in silk 1910.
Extension fixture includes flexible bellow (Figure 11 A to 11F) after another expansion disclosed herein.Such flexibility Bellows can have the first construction, and wherein bellows extends and substantially lain flat against on delivery apparatus 10.It can also have There is the second construction, wherein bellows shortens or shrinks or expand.Compared with when in its first construction, when in its second structure When making, bellows can have bigger diameter.Some bellowss disclosed herein are shaped like accordion so that when complete During full extension (deploying front construction in it), what it substantially kept flat.However, it is similar to accordion, the receipts of these bellowss Contracting can make its own folding.The behavior of this similar accordion makes the diameter of bellows be improved with its shortening.These ripples Pipe can be fixed relative to the near-end of extension fixture after expansion (that is, the near-end of bellows relative to extension fixture after expansion near-end It is fixed), fix relative to the distal end of extension fixture after expansion (that is, the distal end of bellows relative to after expansion extension fixture it is remote End is fixed), or as an alternative, bellows proximally and distally the two can all independently move.It can be based on comprising only one Extension fixture after the expansion of bellows.However, it can also include more than one (for example, being incorporated to a ripple in each delivery platform Pipe).
Extension fixture includes balloon-expandable (for example, inner core sacculus 2110, figure after other expansion disclosed herein 12A to 12F).Such sacculus can be with the expansion front construction with the first diameter, and it allows sacculus close to delivery apparatus 10 Interior section (so that external jacket 12 can coordinate on sacculus).Sacculus also can be with the deployment configuration with Second bobbin diameter, its Middle sacculus expansion.As will be readily understood, when being placed in substantially fixed volume, the expansion of extra sacculus will be in volume Inner surface on cause extra radial direction or outside pressure.Extension fixture after expansion of the only one based on sacculus can be included.So And it can also include more than one (for example, being incorporated to a sacculus in each delivery platform).Balloon-expandable can be additionally used in blood vessel Wall delivers medicine or biopharmaceuticals.
Sacculus is incorporated to one or more embodiments after deploying in extension fixture also to be included sacculus being limited in it Deploy the spiral winding 2330 (Figure 14 B) of front construction.Spiral winding 2330 can extend from spiral winding chamber 2320 and be retracted into spiral shell Revolve in coil bore 2320 (Figure 14 A).Spiral winding is retracted into chamber can make it discharge sacculus so that Balloon-expandable.Make spiral shell Spin line circle can be such that its spirality is wound around sacculus so that sacculus is limited in against the inside portion of delivery apparatus 10 from chamber extension Point.So (for example, being placed in intracavitary unit, expanded with spiral winding limitation sacculus after sacculus is only used once to open up Intracavitary unit is opened, and is shunk) it is particularly useful.If without spiral winding, the sacculus of contraction may be stuck in biological structure Or on intracavitary unit.However, spiral winding can make the interior section of another tight abutment delivery apparatus of sacculus.
Fig. 8 A to 8G show be incorporated to expansion after extension fixture an embodiment delivery apparatus 10.More specifically, Delivery system includes integrated distal expanding element, its be used to expanding implant after deployment with ensure implant and vascular wall it Between preferable note it is attached.Similar to the delivery apparatus 10 shown in Fig. 7 A, the delivery apparatus 10 shown in Fig. 8 A is included in the first expansion The external jacket 12 of front position.As has been described, multiple nails 2 can be maintained at delivering dress by external jacket 12 with confined state Put in 10, and can extend on the given length of delivery apparatus.Delivery apparatus 10 includes the seal wire that can extend on seal wire 50 Chamber 40 so that delivery apparatus 10 can be advanced into therapentic part on seal wire 50 in patient vessel's system.As has been described, lead Silk 50 can be the identical seal wire used in preceding operating procedure.The second expansion front position can be recalled or be retracted into external jacket 12 (as shown in figures 7 b and 7 c).Deploy front position second, the distal end 52 of external jacket can be placed in nail to be deployed far-end or The slightly distant place of distal end.
As the system shown in preceding figure, external jacket 12 can have radiopaque annulet band 28, and follow closely and also may be used With one or more radiopaque marks 22.Radiopaque mark 22 can surround nail and be disposed with post.As shown in Figure 8 C, following closely It can allow doctor's alignment mark 22,28 before expansion is followed closely with corresponding radiopaque mark 22,28 with external jacket.This Outside, the mark of alignment and desired region alignment to be treated can be made.The visualization technique of standard can be used to be alignd to realize.As Through what is referred to, it can also be radiopaque that the annular in interior axle, which promotes band 44,.
Reference picture 8B, it can be seen that the mark 22 on the nail of mark 28 and first 2 on external jacket 12 aligns, and protects The distal end of set is placed in the distal end of the first nail.Delivery apparatus 10 can be disposed now to be treated relative to focus, for example, it is logical Cross and radiopaque mark centers in desired locations.Then, sheath can be recalled so that nail is placed on into desired locations.In addition to placement Outside portion's sheath 12 make it that nail 2 is deployable, by the mark 22 on radiopaque mark band 28 and first nail 2 on external jacket 12 Alignment also makes to be incorporated to the first platform exposure of extension fixture after expansion.
Fig. 8 B and 8C show extension fixture after the expansion in collapsed state.It is impermeable to include distal end for extension fixture after expansion Ray ring 1720, near-end radiopaque ring 1722 and multiple expansion silks 1710.Distal end radiopaque ring 1720 is generally disposed in exhibition Open the far-end of the platform of rear extension fixture or close to distally.By extension, near-end radiopaque ring 1722 is generally disposed in exhibition Open the near-end of the platform of rear extension fixture or close to near-end.Before extension fixture has fairshaped expansion after expansion shown in Fig. 8 Construction and deployment configuration, it will be discussed in further detail below.Fig. 8 B and 8C are shown deploys the expansion of front construction in it Extension fixture afterwards.
As described above, extension fixture includes multiple expansion silks 1710 after expansion.Expansion silk 1710 can form framework.At some In embodiment, extension fixture has 3 expansion silks 1710 after expansion.In other embodiments, extension fixture after expansion With the expansion silk 1710 of distal end 4,5,6,7,8,9,10,11 or 12.In other embodiments, extension fixture has after expansion There are more than 12 expansion silks 1710.Expansion silk 1710 is by keeping sufficiently rigid its flexible material system that can radially outward promote that causes Into as will be discussed below.In some embodiments, expansion silk 1710 is made up of polymer.In other embodiments In, expansion silk 1710 is made up of metal such as superelastic metal (such as Nitinol (nitinol)).It is each to expand the remote of silk 1710 End part can preform to allow and the inner surface optimum engagement of implant and then expand implant.In some embodiments In, each silk 1710 of expanding is covered by thin flexible polymeric film.This can advantageously help expansionary force being more equally among distributed in In the surface region of endovascular device.Polymer film, which also assists in, mitigates the structure that the silk during expansion is entangled to endovascular device In possibility.Polymer film can also be used to medicine or biopharmaceuticals being delivered to vascular wall.Or in other embodiment party In case, expansion silk 1710 can be embedded in the wall of very thin very flexible continuous expansible structure (such as sacculus).So It is embedded advantageously to prevent that expanding silk 1710 tangles and/or block on the pillar or anchor log of the nail 2 just deployed.
As indicated, the distal portions of each expansion silk 1710 extension fixture platform after expansion in multiple expansion silks 1710 Distal end (for example, close to distal end radiopaque ring 1720) fixed relative to interior axle 26.It is around delivery apparatus 10 with substantially phase Deng segmentation fix.For example, extension fixture has in the embodiment of only 3 expansion silks 1710 after deployment, silk is each expanded 1710 are separated by about 120 ° with next expansion silk 1710.In an identical manner, extension fixture has 6 expansions after deploying wherein In one embodiment of the delivery apparatus 10 of silk 1710, each silk 1710 of expanding is separated by about 60 ° with next expansion silk 1710.
Expansion silk 1710 proximally extends from it relative to the attachment point of interior axle 26, crosses the flat of extension fixture after expansion Platform, and in the lower section of annulet band 44 and multiple delivery platforms 8, until the near-end of delivery apparatus 10.Multiple expansion silks 1710 each can individually extend to the near-end of delivery apparatus 10.Or multiple expansion silks 1710 can be expanded after deployment The near-end of apparatus platform is bonded together to form single cable, and it extends proximally into the near-end of delivery apparatus 10.Each expansion silk The proximal part of 1710 (or as just discussed, including single cable of respective and each expansion silk 1710) is fixed on delivery apparatus 10 The sprawl and control part 1730 of near-end, it can be activated by user such as doctor.
In some embodiments, interior axle 26 is extruded so that comprising multiple chambers, expanding silk 1710 by the chamber can be from exhibition Open the near-end that rear extension fixture advances to delivery apparatus 10.Interior axle 26 can be made up of multi-cavity extrusion, as shown in Figure 9 A.Fig. 9 A show The section of interior axle 26 is gone out, it has the guidewire lumen 40 of the heart wherein, and guidewire lumen 40 is arranged essentially parallel in its wall Six independent silk chambers 1810.Expansion silk 1710 can extend to delivering dress by these extension fixtures after expansion of chamber 1810 Put 10 near-end.Silk chamber 1810 extends to multiple expansions of distal portions generally by the near-end of silk chamber 1810 from delivery apparatus 10 Pull spring 1710, which provides, to be supported and coaxially accommodates.
As will be readily understood, interior axle 26 can include any number of silk chamber 1810, including 3 silk chambers 1810.At some In embodiment, interior axle 26 has 4,5,6,7,8,9,10,11 or 12 silk chambers 1810.In other embodiments, interior axle 26 have be more than 12 silk chambers 1810.Each silk chamber 1810 can accommodate an expansion silk 1710.For example, interior axle 26 is extrudable for tool There is a number of silk chamber 1810 (for example, 8 silk chambers 1810), then by (that is, 8 expansions of expansion silk 1710 of identical quantity 1710) silk is inserted in silk chamber 1810.The system that such 1: 1 ratio can be used for height regulation.However, by contrast, some are squeezed The silk chamber 1810 gone out can remain sky.For example, it is (for example, 12 silks with relatively great amount of silk chamber 1810 that interior axle 26 is extrudable Chamber 1810).Then, the expansion silk 1710 (for example, 6 expansion silks 1710) of desired amt is inserted only into silk chamber 1810.It is this The system of type is more modular and can reduce manufacturing cost, because single extrusion interior axle 26 can accommodate the expansion of varying number Silk 1710.
As shown in Figure 9 B, expansion silk 1710 can leave a chamber 1810 with across the surface (example of extension fixture platform after expansion Such as, the outer surface of interior axle 26) extension.In some embodiments, the distal portions of the multi-cavity extrusion with silk chamber 1810 exist Several machine-direction oriented openings or pocket (for example, each 1,810 1 openings of silk chamber or pocket) are incorporated in the wall of extrusion.Window The distal portions of mouth or pocket generally with silk chamber 1810 in inner core multi-cavity extrusion align, and enable to exposure expansion silk 1710 Distal portions (for example, expansion silk 1710 can leave these windows with travel across expansion after extension fixture platform surface it is straight To its respective attachment point).Or as shown in Figure 9 B, expansion silk 1710 can reside in multiple grooves 1820, the silk groove 1820 be the extension on the substantially spacious top of a chamber 1810.Space can be advantageously saved using such silk groove 1820, is prevented Expansion silk 1710 interacts with each other, and prevents the combination between external jacket 12, expansion silk 1710 and interior axle 26 and/or mistake Degree friction.
In some embodiments, expand silk 1710 can adjacent push band 44 leave a chamber 1810.By this way, promote With 44 rigidity and structural intergrity that can be used for raising internals 26.Precentrum 38 can also use by this way.For example, The metal radiopaque mark band in band 44 and in precentrum 38 is promoted to surround the outlet port of the neighbouring expansion silk of silk chamber 1710. This can help to delivery apparatus and the stress improved on internals handled when expanding silk in an expanded position.As already mentioned , extension fixture is proximally and distally after promoting band and precentrum to limit expansion respectively.
As indicated, after deployment before the expansion of extension fixture under state, each silk 1710 of expanding substantially is lain flat against In interior axle 26 (or in silk groove 1820 of interior axle 26).In the pre-deployed under state, it is each expand have in silk 1710 seldom (if If) relaxation.That is, the fixing point of extension fixture platform distal end and silk chamber 1810 are remote after deployment at it for expansion silk 1710 The same length of extension fixture platform after length and expansion between end.
The startup of expanding mechanism is distally advanced a transit chamber, and this distal portions for further resulting in silk passes through extrusion Opening radial dilatation in wall.Deploy (that is, the startup of expanding mechanism) by multiple expansion silks 1710 (or by multiple expansion silks 1710 formed cables) near-end promote realize.This makes expansion silk 1710 be extended out from the distal end of its chamber 1810 (for example, silk The distal end of transit chamber promotes) so that the distal portions of expansion silk 1710 are extended by silk chamber 1810 and radial dilatation, this enters One step causes the distal portions of silk by the opening radial dilatation of extrusion wall.The extension for expanding the distal portions of silk 1710 improves The length of expansion silk 1710 after expansion between the attachment point of extension fixture distal end and the distal end of silk chamber 1810.With being expanded after expansion The length that silk 1710 is expanded on device improves, and it will outwards " bending ".More expansion silks 1710 are released into a chamber 1810 makes expansion Pull spring 1710 is even bent further out.That is, the expansion diameter of expansion silk 1710 is by the vertical of the near-end of expansion silk 1710 To Bit andits control.
Fig. 8 D to 8G show the method using extension fixture after the expansion just discussed.In Fig. 8 D, external jacket 12 It has been retracted that, as this paper other parts are discussed.Radiopaque mark band 28 has been retracted, until itself and the weight of radiopaque mark 22 It is folded, prepare the nail of expansion second 2.As can be seen that the first self expandable nail 2 has been expanded into substantially note and invests cavity wall.When outside Sheath 12 accommodate when, follow closely 2 radiopaque mark 22 be generally proximal to together be in close packing ring.By contrast, 2 expansion is followed closely Opening makes radiopaque mark 22 also expand outwardly, so as to form more dispersed ring.Therefore, doctor uses such as other parts herein The standard imaging techniques of discussion can be observed nail 2 and depart from from its delivery platform 8 and expand in the blood vessels.It is implanted into independent self expandable During the expansion of thing (for example, nail 2), silk is fully accommodated in pocket/groove and inner core wall.
Once nail 2 has been unfolded into its target location and stops expansion in the blood vessels (that is, it was observed that radiopaque marks 22 no longer move or hardly move), by delivery apparatus 10 proximally or distal end is mobile and relocate so that expanded after expansion Device is moved to the lower section of nail 2, as illustrated in fig. 8e.In the position, the exposed distal end of expansion silk 1710 is centrally located at the plant of expansion Enter the approximate center of thing.
A part for interior axle 26 or a part for expansion silk 1710 can include one or more radiopaque elements, to permit Perhaps it is optimal longitudinally-aligned in the implant of expansion to expand silk 1710.For example, expansion after extension fixture may be incorporated into distal end do not transmit Wire loop 1720 and near-end radiopaque ring 1722, it can be used for centering extension fixture after expansion at the center of nail 2.Distal end is not Conventional imaging technique can be used to observe for transmission wire loop 1720 and near-end radiopaque ring 1722, as radiopaque mark 22 1 Sample.Therefore, doctor can promote or retract delivery apparatus 10, until radiopaque mark 22 is located substantially on distal end radiopaque ring 1720 and the centre of near-end radiopaque ring 1722.Now, nail 2 by be located substantially at expansion after extension fixture center-startup exhibition Open the correct position of rear extension fixture.
When extension fixture centers below implant after expansion, can expanded by the near-end in expansion silk 1710 Promoted on the near-end of silk 1710 or on the near-end of the cable comprising expansion silk 1710 to distal end to start expanding mechanism.As above Described, this, which makes to expand in the pocket or groove that each expansion silk 1710 is cut from its distal end, comes out.As shown in Figure 8 F, silk 1710 is expanded Radial dilatation or " bending " silk is engaged with the inner surface of Vascular implant.As expansion silk 1710 continues radial dilatation, its Continuation radially outward promotes on the inner surface of Vascular implant, so as to which the implant of expansion is fully expanded against in blood vessel Wall.
After 2 be fully deployed of radial dilatation and nail of expansion silk 1710, can by the near-end in expansion silk 1710, Expand on the near-end of silk 1710 or be proximally pulled on the near-end of the cable comprising expansion silk 1710 to disable expanding mechanism. As described above, this causes each expansion silk 1710 to be retracted into the pocket or groove of its distal end incision, to be resisted against interior axle 26 again On, as shown in fig. 8g.
Although Fig. 8 A are described as being located at the distal end of delivery apparatus 10 at tip 38 to extension fixture after the expansion shown in 8F Between the nail 2 of distalmost end, but it is to be understood that extension fixture after multiple such expansion can be included in delivery apparatus 10. For example, can after an expansion is below incorporated into each nail 2 extension fixture (for example, multiple expansion silk 1710), for example, being incorporated into nail Platform below 2.In some such embodiments, can have can be in the near-end of delivery apparatus 10 for extension fixture after each expansion The control piece of acquisition.Therefore, user's regracting external jacket 12 follows closely 2 with expansion, and without mobile delivery apparatus 10 Extension fixture after implant so as to expand after starting the expansion below nail 2.
Fig. 8 A to 8G show be incorporated to expansion silk 1710 expansion after extension fixture delivery apparatus 10, the expansion Silk 1710 fixes the distal end of extension fixture after deployment, and relative to extension fixture after expansion (and as overall delivering Device 10) near-end it is translatable/extensible.Figure 10 A to 10F delivery apparatus 10 is very similar to Fig. 8 A to 8G delivery apparatus 10.However, in Figure 10 A into 10F, the near-end of expansion silk 1910 is fixed on the near-end of extension fixture after expansion.Also, expand silk 1910 distal translation is so that the expansion radial dilatation of silk 1910.
Figure 10 A to 10C show extension fixture after the expansion in different stages of deployment:Figure 10 A are shown in expansion Extension fixture after the expansion of preceding state (that is, collapsing completely);Figure 10 B expand dress after showing the expansion in the partially unfolded state Put;Figure 10 C show the extension fixture after the substantially completely expansion of deployed condition.
Extension fixture generally comprises distal end radiopaque ring 1720, near-end radiopaque ring 1722 and more after shown expansion Individual expansion silk 1910.Distal end radiopaque ring 1720 and near-end radiopaque ring 1722 can be identical with being described on Fig. 8. In some embodiments, extension fixture has 3 expansion silks 1910 after expansion.In other embodiments, expand after expansion Opening device has the expansion silk 1910 of distal end 4,5,6,7,8,9,10,11 or 12.In other embodiments, expanded after expansion Device has more than 12 expansion silks 1910.Expansion silk 1910 is by keeping sufficiently rigid its flexibility that can radially outward promote that causes Material is made, as will be discussed below.Similar to Fig. 8 expansion silk 1710, expansion silk 1910 can be by polymer or super-elasticity Metal (for example, Nitinol) is made.The distal portions of each expansion silk 1910 can preform to allow the inner surface with implant Optimum engagement and then expand implant.In some embodiments, silk 1910 is each expanded by thin flexible polymeric film Covering.Or in other embodiments, expansion silk 1910 can be embedded in very thin very flexible continuous expansible knot In the wall of structure (such as sacculus).Therefore, expansion silk 1910 can form framework in sacculus.
Compared with Fig. 8, the proximal part of each expansion silk 1910 extension fixture after expansion in multiple expansion silks 1910 The near-end (for example, close to near-end radiopaque ring 1722) of platform is fixed relative to interior axle 26.It is around delivery apparatus 10 with big Equal segmentation is caused to fix.For example, extension fixture has in an embodiment of only 3 expansion silks 1910 after deployment, often Individual expansion silk 1910 is separated by about 120 ° with next expansion silk 1910.In an identical manner, extension fixture has after deploying wherein It is each to expand silk 1910 and next expansion silk 1910 in an embodiment for having the delivery apparatus 10 of 6 expansion silks 1910 It is separated by about 60 °.In some embodiments, expand the near-end extension fixture platform after deployment of silk 1910 near-end be attached in Axle 26.In other embodiments, expansion silk 1910 back extends some distances in the wall of interior axle 26, such as through silk chamber 1810, as described on Fig. 9 A.In some such embodiments, circumference and footpath of multiple expansion silks 1910 around interior axle 26 Alignd to the pocket (such as Fig. 9 A silk chamber 1810) of segmentation, and the wall lumen of interior axle 26 is terminated in the near-end of first volume hooked nail 2 Interior fixed position.
Expand silk 1910 from it relative to the attachment point of interior axle 26 to distal end to extend, cross the flat of extension fixture after expansion Platform, and it is attached to sliding sleeve 1920.When undeployed, expansion silk 1910 may be housed in pocket or groove, as already described 's.Expanding the length (for example, when straight and when not bending) of silk 1910, such that sliding sleeve is placed in its under preloading relative " original (home) " position (for example, close to distal end radiopaque ring 1720), as shown in Figure 10 A.Sliding sleeve operationally joins The sprawl and control part 1730 in the near-end of delivery apparatus 10 is connected to, such as leads contracting part (retractor).Leading contracting part allows user to make Sliding sleeve 1920 coaxially slides along interior axle 26.In some embodiments, it can be simply to be attached to cunning to lead contracting part An a series of silk or silks for dynamic sleeve pipe, it extends across the surface of extension fixture platform after deployment, extends into interior axle 26 (for example, by silk chamber 1810) and the near-end of delivery apparatus 10 is extended in wall.
In operation, leading contracting part can proximally be pulled, so that surface of the sliding sleeve 1920 along interior axle 26 is near Slide at end.Figure 10 B show the sliding sleeve 1920 that proximally part is slided.Figure 10 C are shown in near-end The sliding sleeve 1920 further slided on direction.As discussed above, expanding silk 1910 has fixed length.Cause This, sliding sleeve 1920 is proximally slided towards the attachment point of expansion silk 1910 and interior axle 26 makes expansion silk 1910 outwards " curved It is bent ".Sliding sleeve 1920 is further proximally slided makes expansion silk 1910 further be bent outwardly.That is, expand The expansion diameter of pull spring 1910 is controlled by the length travel of sliding sleeve 1920.
Figure 10 D to 10F show the application method of extension fixture after the expansion just discussed.In figure 10d, external jacket 12 have retracted, until radiopaque mark band 28 is overlapping with radiopaque mark 22 (that is, until delivery apparatus 10 prepares to deploy Second nail is 2).As shown in Figure 10 D, the first self expandable nail 2 has been expanded into substantially note and invests cavity wall.It is implanted into independent self expandable During the expansion of thing (for example, nail 2), silk can be fully accommodated in pocket/groove and inner core wall.
Once nail 2 has been deployed into its target location and has stopped expansion in the blood vessels (that is, it was observed that radiopaque marks 22 no longer move or hardly move), by delivery apparatus 10 proximally or distal end is mobile and relocate so that expanded after expansion Device is moved to the lower section of nail 2, as shown in figure 10e.In the position, the expansion silk 1910 of exposure is centrally located at the nail 2 of expansion Approximate center.
Radiopaque mark (such as distal end radiopaque ring 1720 and near-end radiopaque ring 1722) can be used so that exhibition Rear extension fixture is opened to align with nail 2.In some embodiments, distal end radiopaque ring 1720 and near-end radiopaque ring 1722 For the center of 2 alignment extension fixtures after deployment will to be followed closely.In other embodiments, near-end radiopaque ring 1722 is pacified It is set to the radiopaque mark 22 (being shown in 10E) closer to nail 2.Near-end radiopaque ring 1722 is marked closer to radiopaque 22 to place can be useful because after expansion extension fixture maximum deployment diameter deviation near-end radiopaque ring 1722 (with System shown in Fig. 8 is compared).As sliding sleeve 1920 moves proximally to, deployment diameter increase.Therefore, doctor can promote or Retraction delivery apparatus 10, until radiopaque mark 22 is placed exactly in the distal end of near-end radiopaque ring 1722.Now, nail 2 can Start the correct position of extension fixture after expansion for the sufficiently large position one of nail 2 positioned at deployment diameter.
, can be by proximally being pulled on contracting part is led when extension fixture is located at the desired locations below implant after expansion To start expanding mechanism.As described above, this sliding sleeve 1920 proximally to slide and expands silk 1910 radially outward to expand , as shown in figure 10e.As shown in figure 10e, expanding the radial dilatation of silk 1910 or " bending " makes the interior table of silk and Vascular implant Face engages.As expansion silk 1910 continues radial dilatation, its continuation radially outward promotes on the inner surface of Vascular implant, from And by the fully expanded inwall against blood vessel of the implant of expansion.
, can be by (such as being delivered on contracting part is led after 2 be fully deployed of radial dilatation and nail of expansion silk 1910 The near-end of device 10) promoted to distal end to disable expanding mechanism.As described above, this makes each expansion silk 1910 be retracted into its distal end To lie flat against again in interior axle 26 in the pocket or groove of incision.
Although Figure 10 A are described as being located at the distal end of delivery apparatus 10 at tip to extension fixture after the expansion shown in 10F Between 38 and the nail 2 of distalmost end, but it is to be understood that expansion dress after multiple such expansion can be included in delivery apparatus 10 Put.For example, can it is each nail 2 be below incorporated into one expansion after extension fixture (for example, sliding sleeve 1920 and multiple expansion silks 1910), for example, be incorporated to nail 2 below platform.In some such embodiments, can have can for extension fixture after each expansion In the close control piece of the near-end of delivery apparatus 10.Therefore, user's regracting external jacket 12 follows closely 2 with expansion, and need not Extension fixture after implant so as to expand after mobile delivery apparatus 10 can start the expansion followed closely below 2.
Figure 11 A to 11F are shown with the delivering dress for being incorporated to extension fixture after the expansion of preformed expandable frame Put 10.Framework can be bellows.This delivery apparatus 10 is very similar to Figure 10 A to 10G delivery apparatus 10.However, to the greatest extent Extension fixture is incorporated to the multiple expansion silks 1910 for being attached to sliding sleeve 1920 after expansion shown in pipe Figure 10, after Figure 11 expansion Extension fixture is incorporated to the expansible bellows 2010 for being attached to slip ring or sleeve pipe 2020 (being similar to sliding sleeve 1920).
Figure 11 A to 11C show extension fixture after the expansion in different stages of deployment:Figure 11 A are shown in expansion Extension fixture after the expansion of preceding state (that is, collapsing completely);Figure 11 B expand dress after showing the expansion in the partially unfolded state Put;Figure 11 C show the extension fixture after the substantially completely expansion of deployed condition.
Extension fixture generally comprises bellows 2010 after expansion.The near-end of bellows 2010 is generally proximal to or expanded after deployment The near-end for opening apparatus platform is attached to interior axle 26.The distal attachment of bellows 2010 is to sliding sleeve or ring 2020.Sliding sleeve 2020 can be operably linked to the near-end of delivery apparatus 10 sprawl and control part 1730 or lead contracting part.Leading contracting part allows to use Person makes sliding sleeve 2020 coaxially be slided along interior axle 26.In some embodiments, it is simply to be attached to cunning to lead contracting part A series of silks of dynamic sleeve pipe 2020, it extends across the surface of extension fixture platform after expansion, extends into (example in the wall of interior axle 26 Such as, by silk chamber 1810) and extend to the near-end of delivery apparatus 10.
Sliding sleeve 2020 can be placed in its relative " original " position (for example, close to distal end radiopaque ring 1720), such as Shown in Figure 11 A.In some embodiments, it is desired to some axial forces make the sliding sleeve 2020 be maintained at its distal-most position. In some such embodiments, it can be used and lead contracting part to provide such axial force in a distal direction.After deployment Under the undeployed configuration of extension fixture, when sliding sleeve 2020 is located at its " original " position, bellows 2010 is substantially kept flat Against on the platform of extension fixture after deployment.
In operation, can will lead contracting part to move proximally to, so that surface of the sliding sleeve 2020 along interior axle 26 is near Slide at end.In some embodiments, contracting part will be led proximally to pull.However, in other embodiments, only reduce distal end Axial force on direction, which can make to lead contracting part, to be moved proximally to.Figure 11 B show what is partly slided in the proximal direction Sliding sleeve 2020.Figure 11 C show the sliding sleeve 2020 slided in the proximal direction or even further.Make slip cap Pipe 2020 proximally slides towards the attachment point of bellows 2010 and interior axle 26 folds bellows 2010.With the folding of bellows 2010 It is folded, its basically straight protector configurations movement be with ripple pipe diameter 2020 have multiple bellows recesses 2012 with it is more The accordion sample construction of individual bellows ridge 2014.Reference picture 11B and 11C can be seen that ripple pipe diameter 2020 by sliding sleeve 2020 length travel control.That is, as sliding sleeve 2020 even further moves proximally to, bellows 2010 will Even more fold, make the even further increase of ripple pipe diameter 2020.Bellows 2010 can be by being formed as the framework with lid It is made with producing many silks of recess 2012 and ridge 2014.For example, silk can be wound with spiral structure.Framework may move so that One end is moved closer to the other end so that ripple enlargement of pipe.
Figure 11 D to 11F show the application method of extension fixture after the expansion just discussed.Methods described substantially with pass It is identical in the method that Figure 10 D to 10F are described.Briefly, nail 2 is deployed in vascular system, then will be one or more Radiopaque is marked to cooperate with the radiopaque mark 22 of nail 2 and used so that extension fixture aligns with nail 2 after expansion.Once according to It is expected that nail 2 aligns with extension fixture after expansion, sliding sleeve 2020 is set to move in the proximal direction to open by using contracting part is led Extension fixture after dynamic expansion.With the movement of sliding sleeve 2020, bellows 2010 folds and increases its ripple pipe diameter so that Bellows ridge 2014 contacts with the inner surface of nail 2.As bellows 2010 continues radial dilatation, (that is, ripple pipe diameter continues to increase Greatly), its continuation radially outward promotes on the inner surface of Vascular implant, so that the implant of expansion is fully expanded against blood The inwall of pipe.
Although Figure 11 A are described as being located at the distal end of delivery apparatus 10 at tip to extension fixture after the expansion shown in 11F Between 38 and the nail 2 of distalmost end, but it is to be understood that expansion dress after multiple such expansion can be included in delivery apparatus 10 Put.For example, extension fixture (for example, bellows 2010) after an expansion can be incorporated to below each nail 2, for example, being incorporated to nail 2 Following platform.In some such embodiments, can have can be in the near of delivery apparatus 10 for extension fixture after each expansion Hold close control piece.Therefore, user's regracting external jacket 12 follows closely 2 with expansion, and is without mobile delivery apparatus 10 Extension fixture after implant so as to expand after the expansion below nail 2 can be started.
Figure 12 A to 12F show another embodiment of delivery apparatus 10, its have be incorporated to the expansion of sacculus after expand Device.Figure 12 A to 12C show extension fixture after the expansion in different stages of deployment:Figure 12 A show the shape before expansion Extension fixture after the expansion of state (that is, collapsing completely);Figure 12 B are shown in the partially unfolded state (that is, only demi-inflation) Extension fixture after expansion;Figure 12 C expand dress after showing the expansion in substantially completely deployed condition (that is, expansion completely) Put.
Extension fixture generally comprises distal end radiopaque ring 1720, near-end radiopaque ring 1722 and inner core sacculus after expansion 2110.Distal end radiopaque ring 1720 and near-end radiopaque ring 1722 can be identical with being described on Fig. 8.Inner core sacculus 2110 can be constructed by the elastomeric material (such as silicone, nylon or polyurethane) of compliance.
Inner core sacculus 2110 can be from the distal end extension of extension fixture platform after substantially distal end radiopaque ring 1720 or expansion The near-end of the platform of extension fixture after to substantially near-end radiopaque ring 1722 or expansion.As shown in figure 12, inner core sacculus 2110 It can be placed in inner spindle (for example, interior axle 26) in implant (such as unexpanded nail 2) distal end.It will be appreciated, however, that inner core Similar aufbauprinciple can be used to be placed on external jacket 12 for sacculus 2110.
In some embodiments, inner core sacculus 2110 has diameter before the only slightly greater than expansion of interior axle 26.So Some embodiments in, diameter is sufficiently small before expansion so that inner core sacculus 2110 can reside in interior axle 26 and external jacket 12 Between.In some embodiments, inner core sacculus 2110 can have about 8mm fully expanded diameter.In other embodiments In, the expansion diameter of inner core sacculus 2110 is about 0.4,0.6,0.8,1,1.2,1.4,1.6,1.8,2,2.2,2.4,2.6,2.8, 3、3.2、3.4、3.6、3.8、4、4.2、4.4、4.6、4.8、5、5.2、5.4、5.6、5.8、6、6.2、6.4、6.6、6.8、7、 7.2nd, 7.4,7.6,7.8,8,8.2,8.4,8.6,8.8,9,9.2,9.4,9.6,9.8 or 10mm.In another embodiment, 2110 have suitable for making any other expansion diameter that vascular devices are fully deployed in the vascular system of object.
Inner core sacculus 2110 can be by being transferred to inner core sacculus from delivery apparatus 10 proximally by one or more chambers 2110 fluid expansion.In some embodiments, interior axle 26 is extruded can pass through institute comprising one or more chambers, fluid State chamber and advance to the other end from one end of delivery apparatus 10.Interior axle 26 can be made up of multi-cavity extrusion, and as shown in FIG. 13A, it shows Go out in interior axle of the center with guidewire lumen 40 and with two fluid cavitys 2220 for being arranged essentially parallel to guidewire lumen 40 in wall 26.Fluid (for example, gas or liquid fluid) can be pumped into the distal end of delivery apparatus 10 from the near-end of delivery apparatus 10.For example, Extension fixture is so that inner core sacculus 2110 expands after fluid can be pumped into Figure 12 A to 12F expansion from the near-end of delivery apparatus 10. Some embodiments can include coaxial guard system, and one example is shown in Figure 13 B, rather than as described above and shown in Figure 13 A Multi-cavity extrusion.Coaxial guard system can include multiple coaxially arranged pipes, including such as two or more coaxially arranged pipes, Shown in embodiment as shown.In the illustrated embodiment, outer tube 262 can extend at least a portion of inner tube 261, institute Guidewire lumen 40 can be limited by stating inner tube 261.Fluid cavity 2221 can be limited by the outer surface of inner tube 261 and the inner surface of outer tube 262.It is logical Cross comprising the coaxially arranged pipe of more than two, more than one coaxial flow body cavity can be formed.For example, three pipes will limit two fluids The guidewire lumen of chamber and the wherein heart.Also, four pipes will limit three fluid cavitys and the wherein guidewire lumen of the heart.It should be appreciated that Such multithread lumen of body system can be used for different fluids being delivered to single balloon-expandable, or it can be used for identical Fluid is delivered to multiple sacculus, or it can be used for different fluid being delivered to multiple sacculus.Sacculus can be with several different Mode is attached to such coaxial guard system.For example, in one embodiment, the distal end of sacculus is attachable (in some implementations With fluid-tight seal in scheme) arrive inner tube 261 distal end.The near-end of sacculus is attachable (to be used in some embodiments Fluid-tight seal) arrive outer tube 262 distal end.In such construction, inner tube can be to provide the passage for seal wire Guidewire lumen 40, and outer tube can limit the annular ex-pansion fluid cavity 2221 with the internal fluid communication of sacculus.Annular ex-pansion stream Body cavity 2221 can provide for expanding fluid so that sacculus expansion and the passage shunk.
As will be readily understood, although showing two fluid cavitys 2220, interior axle 26 can include only 1 fluid cavity 2220. In some embodiments, interior axle 26 includes 3, distal end 4,5,6,7 or even 8 fluid cavitys 2220.In other implementations In scheme, interior axle 26, which includes, is more than 8 fluid cavitys 2220.
In operation, as shown in Figure 12 A to 12F, fluid can be pumped into inner core sacculus 2110 from the near-end of delivery apparatus 10, So that inner core sacculus 2110 expands.The different amounts of fluid for being pumped into or being injected into inner core sacculus 2110 can be in inner core sacculus Different amounts of radial pressure is produced on 2110 wall.Figure 12 A are shown almost to collapse against interior completely in state before its expansion The inner core sacculus 2110 of axle 26.Figure 12 B show the inner core sacculus 2110 only partially expanded.Finally, Figure 12 C are shown The inner core sacculus 2110 expanded completely.Finally, the expansion of inner core sacculus 2110 is by being pumped into the fluid of inner core sacculus 2110 Measure to control.In some embodiments, the pressure that delivery apparatus 10 includes the pressure that can be detected in inner core sacculus 2110 passes Sensor.In some such embodiments, pressure sensor can advantageously with pump (its near-end by fluid from delivery apparatus 10 It is pumped into inner core sacculus 2110) connection so that pump can be automatically stopped pumping before the burst pressure of inner core sacculus 2110 is reached.
Figure 12 D to 12F show the method using extension fixture after the expansion just discussed.In fig. 12d, external jacket 12 have retracted, until radiopaque mark band 28 is overlapping with radiopaque mark 22 (that is, until delivery apparatus 10 prepares to deploy Second nail is 2).As shown in Figure 10 D, the first self expandable nail 2 has been expanded into substantially note and invests cavity wall.It is implanted into independent self expandable During the expansion of thing, inner core sacculus 2110 shrinks against the external diameter of interior axle 26 completely.
Once nail 2 has been deployed into its target location and has stopped expansion in the blood vessels (that is, it was observed that not transmission mark 22 No longer move or hardly move), by delivery apparatus 10 proximally or distal end is mobile and relocate and make it that expansion fills after deploy The lower section for being moved to nail 2 is put, as shown in figure 12e.In the position, inner core sacculus 2110 is centrally located at the nail 2 that substantially deploys Center.
As discussed above, radiopaque mark (such as distal end radiopaque ring 1720 and near-end radiopaque can be used Ring 1722) extension fixture after expansion is alignd with nail 2.In some embodiments, using distal end radiopaque ring 1720 and closely Radiopaque ring 1722 is held to follow closely the center of 2 alignment extension fixture after deployment.In other embodiments, near-end does not transmit Wire loop 1722 is positioned to the radiopaque mark 22 closer to nail 2.
When extension fixture is located at the desired locations below implant after expansion, can by by fluid from delivery apparatus 10 Near-end pumping is by one or more fluid cavitys 2220 and being pumped into inner core sacculus 2110 expands inner core sacculus 2110.Such as Upper described, this causes the outward radial of inner core sacculus 2110 to expand, as Figure 12 E (showing that part is expanded) and Figure 12 D (are shown several It is fully expanded) shown in.As shown in figure 12e, the radial dilatation of inner core sacculus 2110 cause the outer surface of inner core sacculus 2110 with The inner surface engagement of Vascular implant.As inner core sacculus 2110 continues radial dilatation, it continues the interior table in Vascular implant Radially outward promoted on face, so that the fully expanded inwall against blood vessel of implant of expansion.
After 2 be fully deployed of radial dilatation and nail of inner core sacculus 2110, expansion stream can be removed for example, by passing through Body makes inner core sacculus 2110 shrink to disable expanding mechanism.In some embodiments, expansion fluid is removed on one's own initiative, for example, it is logical Cross and see fluid pump off.In other embodiments, expansion fluid is passively removed, such as by simply opening discharge Valve simultaneously allows expansion fluid to be flowed out due to existing pressure differential.Sacculus is set to retract as described above, shrinking inner core sacculus 2110 (such as elasticity due to inner core sacculus 2110) and interior axle 26 is lain flat against again.
Although Figure 12 A are described as being located at the distal end of delivery apparatus 10 at tip to extension fixture after the expansion shown in 12F Between 38 and the nail 2 of distalmost end, but it is to be understood that expansion dress after multiple such expansion can be included in delivery apparatus 10 Put.For example, extension fixture (for example, inner core sacculus 2110) after an expansion can be incorporated to below each nail 2, such as it is incorporated to nail Platform below 2.In some such embodiments, can have can be in the near of delivery apparatus 10 for extension fixture after each expansion Hold close control piece.Therefore, user's regracting external jacket 12 follows closely 2 with expansion, and is without mobile delivery apparatus 10 Extension fixture after implant so as to expand after the expansion below nail 2 can be started.
In order to help that the limitation of inner core sacculus 2110 is resisted against in interior axle 26, expansion, which is filled with, after using expansion deploys nail 2 Before and after, taenidium 2330 all can be used.Taenidium 2330 can have spiral distal end and long substantially straight near Hold the fine filaments of part.As shown in Figure 14B, the spiral distal end of taenidium 2330 needs only extension fixture and inner core ball after deployment It is spiral in the region of capsule 2110.The remainder of taenidium 2330 can be straight, back extend through interior axle 26 and reach The near-end of delivery apparatus 10.
Figure 14 A show the interior axle for being extruded as including multiple chambers, include 40, two fluids of guidewire lumen of the center Chamber 2220 and taenidium chamber 2320 (being shown as accommodating taenidium 2330).Taenidium 2330 extension fixture platform can lead to after expansion Cross the near-end that taenidium chamber 2320 extends back delivery apparatus 10 always.In one embodiment, taenidium chamber 2320 can include In the outer tube 262 of coaxial guard system as described above.In such a embodiment, outer tube can include taenidium chamber 2320, both of which extends in coaxially arranged inner tube 262.When using the coaxial guard system with taenidium chamber 2320, ball Capsule can advantageously be attached to the inner surface of outer tube 262.By this way, taenidium 2330 can be easily and smoothly from taenidium chamber 2320 extend and extend on sacculus.
Taenidium 2330 is preferably by keeping enough rigidity to cause it to regain the soft of its shape after a deformation Property material is made, as will be discussed below.In some embodiments, taenidium 2330 is made up of polymer.At other In embodiment, taenidium 2330 is made up of metal such as superelastic metal (such as Nitinol).
Before the expansion shown in Figure 14 B under state, taenidium 2330 is helically wound around inner core sacculus 2110. After extension fixture centers below the nail 2 of expansion after nail 2 has deployed and deployed, near-end drawing can be used and reverse fortune One or more make taenidium 2330 be retracted from inner core sacculus 2110 so that taenidium 2330 is retracted into taenidium chamber in dynamic In 2320.As taenidium 2330 is retracted into taenidium chamber 2320, its spiral distal portions is by elastic deformation.Work as taenidium 2330 when recalling completely from inner core sacculus 2110, can use inner core sacculus 2110 as described above.
After using inner core sacculus 2110, as described above shrink inner core sacculus 2110.Then, taenidium 2330 can be used In capture and accommodate shrink after inner core sacculus 2110 external diameter so that inner core sacculus 2110 crossing section minimize, so as to Mitigate potential phase of the implant (for example, follow closely 2) of inner core sacculus 2110 and expansion after the contraction of irregular shape between blood vessel Interaction.For recapture inner core sacculus 2110, promoted using distal end makes taenidium with one or more in twist motion 2330 back extend taenidium chamber 2320.Extend taenidium chamber 2320 with the spiral distal portions of taenidium 2330, its Its shape is regained due to its elasticity, and helically wound around the inner core sacculus 2110 shunk to limit inner core Sacculus 2110 simultaneously makes its cross profile shunk minimize (being shown in Figure 14 B).Some embodiments of taenidium 2330 include circle Shape or the distal tip of passivation, to prevent from catching on and/or block the material of inner core sacculus 2110.
After taenidium 2330 back extends taenidium chamber 2320, can make delivery apparatus 10 proximally or distal end Movement after another implant so as to expand.Because taenidium 2330 limits inner core sacculus 2110, the receipts of irregular shape can be mitigated Inner core sacculus 2110 and the risk of the interphase interaction of other structures after contracting.Extension fixture and inner core sacculus 2110 after expansion Desired position is placed in relative to another implant (for example, nail 2), taenidium 2330 can be made to be retracted into taenidium chamber In 2320, so as to allow inner core sacculus to expand.Repeat the successive rear expansion that the process is used for multiple implants.
In another embodiment, instead of retraction taenidium 2330, taenidium 2330 can be made to be released from chamber 2320 with Increase its size.Or filling sacculus 2110 can force taenidium 2330 to be expanded with sacculus, and silk is pulled out from chamber 2320.Remove Fluid can allow taenidium to be tightened up on sacculus, make its with balloon dimension reduce and itself is retracted into chamber.
Although disclose the present invention, art technology in the background of certain preferred embodiments and embodiment Personnel will be understood that the present invention extends to other alternative embodiments and/or use of the present invention beyond specific embodiments disclosed Way and its obvious modification and equivalents.Although in addition, many of the present invention it has been illustrated in detail in and has described Change programme, but present disclosure is based on, other modifications within the scope of the present invention will for those skilled in the art It is obvious.It is also conceivable to the specific features of embodiment and the multiple combinations of aspect or sub-portfolio can be carried out, and It is still fallen within the scope of the present invention.It will thus be appreciated that the various features and aspect of disclosed embodiment can groups each other Close or substitute to form the changing pattern of disclosed invention.Therefore, it is contemplated that the scope of the invention disclosed herein should not be by upper Specific open embodiment limitation is stated, and should be only by being determined to the just reading of appended claims.
Similarly, the method for present disclosure should not be construed as reflecting that any claim needs brighter than in the claim The intention for the more features really recorded.On the contrary, as appended claims are reflected, creative aspect is to be less than any list The combination of all features of individual foregoing open embodiment.Therefore, detailed description of the invention appended claims is hereby clearly simultaneously Enter in this detailed description, wherein each claim is independently as single embodiment.

Claims (34)

1. delivery apparatus, it is included:
Interior axle with the first diameter;
Surround and be fixed on the distal annular rim band of the interior axle;
Surround and be fixed on the proximal annular rim band of the interior axle, wherein the distal annular rim band and the proximal annular rim band have greatly In the Second bobbin diameter of first diameter;
The delivery platform limited by the near-end of the distal annular rim band and the distal end of the proximal annular rim band, wherein the delivering is flat Platform be configured to accommodate be used for from the delivery apparatus be deployed into blood vessel in the distal annular rim band and the proximal annular rim band Between and around the interior axle self expandable intracavitary unit;
The external jacket that on the interior axle and the delivery platform and can be slid on is placed in, the external jacket has The expansion front position of the delivery platform is covered, and at least one recall the external jacket and makes the delivery platform and institute State the delivery location of at least one exposure in distal annular rim band and the proximal annular rim band;And
Expanding unit after expansion, it is included:
The expansion platform fixed relative to the interior axle;And
The multiple expansion silks being radially spaced around the interior axle, the multiple each expansion silk expanded in silk are respectively provided with relatively In the first end that the end of the expansion platform is fixed, the multiple expansion silk is with the pre-activated position with diameter before expansion With the actuated position with more than the deployment diameter of diameter before the expansion;
Expanding unit is configured in the rear to the self expandable intracavitary of the self expandable intracavitary unit expansion after wherein described expansion The inner surface of device applies radial load, to improve the self expandable intracavitary unit in the endovascular expansion and the self expandable Intracavitary unit it is described it is endovascular it is in place at least one of.
2. the delivery apparatus described in claim 1, wherein the delivery platform includes multiple expansion silk grooves, wherein the multiple expansion Each expansion silk in pull spring matches with an expansion silk groove in the multiple expansion silk groove.
3. the delivery apparatus described in claim 1, wherein the multiple expansion silk is configured to when in the pre-activated position In the multiple expansion silk groove so that the multiple expansion silk is located substantially on the lower face of the expansion platform.
4. the delivery apparatus described in claim 1, wherein the multiple expansion silk groove is substantially in the near-end of the delivery platform It is converted into multiple expansion silk chambers.
5. the delivery apparatus described in claim 1, wherein the first end is the remote of each expansion silk in the multiple expansion silk End, it is fixed on the distal end of the expansion platform.
6. the delivery apparatus described in claim 5, wherein the near-end of each expansion silk is configured to remote in the multiple expansion silk End is promoted, and with the distal end of near-end to each expansion silk of each expansion silk it is mobile and make the multiple expansion string diameter to Expansion.
7. the delivery apparatus described in claim 1, it is also on the expansion platform and flat around the expansion comprising being placed in The slip ring of platform, wherein the slip ring is configured to reside between the expansion platform and the external jacket.
8. the delivery apparatus described in claim 7, wherein described in the distal end of each expansion silk is fixed in the multiple expansion silk Slip ring, and wherein described slip ring is configured to proximally be pulled so that the multiple expansion silk radial dilatation.
9. the delivery apparatus described in claim 1, it is also comprising the first and second expansion platform radiopaque bands.
10. the delivery apparatus described in claim 1, wherein the interior axle includes guidewire lumen and multiple expansion silk chambers, wherein described Guidewire lumen is substantially disposed in the center of the interior axle, and the multiple expansion silk chamber is pacified radially around the guidewire lumen Put, wherein the multiple expansion silk chamber is configured to accommodate at least a portion of the multiple expansion silk.
11. the delivery apparatus described in claim 1, it is also comprising the expansion for being configured to control the expansion of expanding unit after the expansion Open control member.
12. the delivery apparatus described in claim 11, wherein the sprawl and control component is located at the near-end of the delivery apparatus.
13. the delivery apparatus described in claim 11, wherein each expansion silk in the multiple expansion silk is flat from the expansion The distal end of platform extends proximally into the sprawl and control component, said multiple expansion silks can to distal end by promotion to increase The diameter of expanding unit after expansion is stated, and is proximally pulled to reduce the diameter of expanding unit after the expansion.
14. the delivery apparatus described in claim 1, wherein the multiple expansion silk proximally prolongs from the distal end of the expansion platform The near-end of the delivery apparatus is extended, extends across the surface of the expansion platform, the substantially near-end in the expansion platform Into multiple expansion silk chambers, the multiple expansion silk chamber is extended through, and substantially left in the near-end of the delivery apparatus Sprawl and control component can be used to be activated for the multiple expansion silk chamber, said multiple expansion silks.
15. the delivery apparatus described in claim 1, wherein at least a portion of the multiple expansion silk is by elastomeric polymer, bullet Property at least one of metal and Nitinol are made.
16. the delivery apparatus described in claim 1, it also includes the self expandable intracavitary unit around delivery platform placement.
17. the delivery apparatus described in claim 1, it includes expanding unit after the second expansion.
18. the delivery apparatus described in claim 1, wherein expanding unit is placed in the distal end of the delivery apparatus after the expansion It is sophisticated between the delivery platform.
19. the delivery apparatus described in claim 1, wherein expanding unit is a part for the delivery platform after the expansion.
20. the delivery apparatus described in claim 1, it includes multiple delivery platforms.
21. the delivery apparatus described in claim 20, it includes expanding unit after multiple expansions.
22. the delivery apparatus described in claim 21, wherein each in the multiple delivery platform and the multiple expansion A pairing in expanding unit afterwards.
23. the delivery apparatus described in claim 22, it also includes the polymeric cover around the multiple expansion silk, described Expand silk and form framework.
24. delivery apparatus, it is included:
Interior axle, the interior axle have precentrum in distal tip;
The delivery platform of the appropriate location in the interior axle is fixed on relative to the precentrum, the delivery platform, which includes, to be fixed In a pair of endless belts of the interior axle, two endless belts are respectively provided with first external diameter;And include the pars intermedia with second external diameter Point, wherein the Second bobbin diameter is less than the first external diameter, and wherein described delivery platform is configured to accommodate and is used for from described Delivery apparatus is deployed into the intracavitary unit in blood vessel, and the delivery platform is configured to be contained between the endless belt and in institute State the intracavitary unit in interior axle;
The external jacket that on the interior axle and the delivery platform and can be slid on is placed in, the external jacket has The expansion front position of the delivery platform is covered, and at least one recall the external jacket and makes the delivery platform at least One endless belt and the delivery location of sleeve pipe exposure;And
It is placed between the precentrum and the delivery platform and comprising expanding unit after multiple expansions for expanding silks, it is described Expansion silk is configured to radial dilatation after actuation with the inner surface after intracavitary unit release in the intracavitary unit It is upper to produce outwardly radial power.
25. delivery apparatus, it is included:
Interior axle;
It is fixed on the distal annular rim band and proximal annular rim band of the interior axle;
Delivery platform between the distal annular rim band and the proximal annular rim band, wherein the delivery platform is configured to accommodate For the self expandable intracavitary unit being deployed into from the delivery apparatus in blood vessel;
The external jacket that can be slided in the interior axle and the delivery platform, the external jacket have the covering delivering flat The expansion front position of platform, and at least one make in the delivery platform and the distal annular rim band and the proximal annular rim band The delivery location of at least one exposure;And
Expanding unit after expansion, it is included:
The expansion platform fixed relative to the interior axle;
The sacculus fixed relative to the longitudinal axis of the expansion platform, the sacculus is with the pre-activated position with diameter before expansion With the actuated position with more than the deployment diameter of diameter before the expansion;
At least one expansion fluid cavity extended with sacculus fluid communication and along at least a portion of the interior axle;
Expanding unit is configured in the rear to the self expandable intracavitary of the self expandable intracavitary unit expansion after wherein described expansion The inner surface of device applies radial load, to improve the self expandable intracavitary unit in the endovascular expansion and the self expandable Intracavitary unit it is described it is endovascular it is in place at least one of.
26. the delivery apparatus described in claim 25, wherein at least one expansion chamber is contained in the wall of the interior axle.
27. the delivery apparatus described in claim 25, it also includes tubulose axle, and the tubulose axle surrounds at least the one of the interior axle Partial-length, and space is produced between the tubulose axle and at least a portion length of the interior axle, wherein the tubulose The outer surface of the inner surface of axle and the interior axle limits at least one expansion chamber.
28. the delivery apparatus described in claim 27, wherein the near-end of the sacculus is fixed on the tubulose axle, and the ball The interior axle is fixed in the distal end of capsule.
29. intracavitary unit method of deploying, it includes:
Delivery apparatus with the intracavitary unit in confined state is advanced to target volume, wherein the delivery apparatus bag Contain:
Interior axle with the first diameter,
Delivery platform with each proximally and distally endless belt of the Second bobbin diameter with more than first diameter, it is described to pass Send platform configuration into accommodate be used for from the delivery apparatus be deployed into volume between the endless belt and around described The intracavitary unit of interior axle,
The external jacket that disposes and can slide on around the interior axle and the delivery platform, the external jacket have Cover the expansion front position of the delivery platform and make the expanded position of the delivery platform exposure,
Expanding unit after expansion comprising multiple expansion silks, the expansion silk are configured to after extension fixture after starting the expansion Radial dilatation is outwardly radial to be produced after the intracavitary unit discharges and expands on the inner surface of the intracavitary unit Power;
The external jacket is recalled to discharge the intracavitary unit;
The intracavitary unit is expanded, wherein the expansion includes allowing the intracavitary unit to expand and expand the intracavitary on one's own initiative One kind in device;
The delivery apparatus is moved so that at least a portion of extension fixture after the expansion is placed in the intracavitary unit of expansion; And
Start extension fixture after the expansion so that at least a portion radial dilatation of extension fixture and in institute after the expansion State and outwardly radial power is produced on the inner surface of the intracavitary unit of expansion.
30. the method described in claim 29, extension fixture after the expansion so as to expand after it also includes the deactivation expansion At least a portion radial contraction of device.
31. the method described in claim 29, it also includes recalling the delivery apparatus from the intracavitary unit of expansion.
32. the method described in claim 29, wherein the delivery apparatus is configured to accommodate and delivers multiple intracavitary units.
33. the method described in claim 32, it also includes:
The each intracavitary unit being discharged into the multiple intracavitary unit in blood vessel is repeated to recall, expanded, mobile and startup Step;And
The delivery apparatus is removed from blood vessel.
34. the method described in claim 29, wherein start extension fixture after the expansion include it is at least one of following:
Pulled at least one expansion silk in the multiple expansion silk;And
Promoted at least one expansion silk of the multiple expansion silk.
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US10245167B2 (en) 2015-01-29 2019-04-02 Intact Vascular, Inc. Delivery device and method of delivery
US11304836B2 (en) 2015-01-29 2022-04-19 Intact Vascular, Inc. Delivery device and method of delivery
US10993824B2 (en) 2016-01-01 2021-05-04 Intact Vascular, Inc. Delivery device and method of delivery
US11660218B2 (en) 2017-07-26 2023-05-30 Intact Vascular, Inc. Delivery device and method of delivery

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HK1247078A1 (en) 2018-09-21
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AU2016380347A1 (en) 2018-05-24
AU2022201306A1 (en) 2022-03-24
CA3003659A1 (en) 2017-07-06
CN107405208B (en) 2020-09-18
EP3397214A1 (en) 2018-11-07
JP2021098047A (en) 2021-07-01
AU2016380347B2 (en) 2019-11-21
JP2019500136A (en) 2019-01-10
AU2020200843A1 (en) 2020-02-27

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