CN101926667B - System and method for conveying and unfolding stopper in blood vessel - Google Patents

System and method for conveying and unfolding stopper in blood vessel Download PDF

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Publication number
CN101926667B
CN101926667B CN 201010259695 CN201010259695A CN101926667B CN 101926667 B CN101926667 B CN 101926667B CN 201010259695 CN201010259695 CN 201010259695 CN 201010259695 A CN201010259695 A CN 201010259695A CN 101926667 B CN101926667 B CN 101926667B
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China
Prior art keywords
stopper
seal wire
retaining member
flexible member
support
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CN 201010259695
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Chinese (zh)
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CN101926667A (en
Inventor
亚伦·李·贝瑞兹
夸恩·库欧克·特兰
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Covidien LP
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Tyco Healthcare Group LP
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Abstract

The invention relates to a system and a method for conveying and unfolding a stopper in a blood vessel. The system and the method for unfolding the stopper can be used for reconstructing an aneurism in the blood vessel through neck reconstruction or saccule reconstruction. The system comprises a guide sheath and a component for carrying the stopper, wherein the component comprises a slender flexible member; the slender flexible member is provided with a stopper keeping member, a keeping member arranged at a near end and a support; the stopper keeping member is used for accommodating a first end of the stopper; the keeping member arranged at the near end is used for engaging a second end of the stopper; the support encircles a part of the slender flexible member; and the stopper can be positioned on the support.

Description

Be used in blood vessel carrying and the system and method for unfolding stopper
The application is that application number is 200580049870.7, and the applying date is on May 25th, 2005, and denomination of invention is divided an application for the application of the system of unfolding stopper " be used in blood vessel carrying and ".
Technical field
The present invention relates generally to a kind of system and method that is used in blood vessel, carrying and launching medical apparatus and instruments; More particularly, the present invention relates to a kind ofly be used in patient's vascular system carrying and launch the intracavitary therapy apparatus with thromboembolism and shutoff the aneurysm especially system and method for cerebral aneurysm.
Background technology
The wall of vascular system, especially arterial wall may form and be called aneurysmal pathologic extended region.As everyone knows, aneurysm has and is easy to disruptive thin, weak walls.Aneurysm possibly be that blood vessel wall receives the result that disease, injury or congenital anomaly weaken.Aneurysm can be present in the intravital different parts of people, and modal is abdominal aortic aneurysm (abdominal aortic aneurysm) and the interior cerebral aneurysm (brain or cerebral aneurysm) of neural vascular system.When the aneurysmal wall that is weakened breaks, can cause death, especially if cerebral aneurysm break.
Usually through getting rid of the weakened part of blood vessel in the external treatment aneurysm of arterial circulation.For the treatment cerebral aneurysm, this reinforcement can be carried out in many ways, comprising: (i) surgical clips is closed (surgical clipping), around aneurysm substrate fixing metal clip; (ii) use little, flexible drum (minicoil) (micro-coil) to fill up aneurysm; (iii) use embolism materials " filling " aneurysm; Be female blood vessel of aneurysm blood supply (iv) with taking off property sacculus (detachable balloon) or bung flange shutoff; And (v) endovascular stent implantation (intravascular stenting).
It is well-known being used to treat narrow (vascular stenose) of vascular or aneurysmal endovascular stent on the medical skill.Support is to expansion or otherwise provide support in order to avoid the prosthesis of blood vessel atrophy (prostheses) at blood vessel or lumen diameter.It also is well-known being used to carry the method for these endovascular stents.
Compressed stent is being introduced blood vessel and be located in the traditional method in narrow zone or in the aneurysm, the guiding catheter that will have distal tip (distal tip) is introduced patient's vascular system via skin.The advancement finger guiding tube is up to the approaching narrow or aneurysm of its distal tip in blood vessel.The far-end that passes guiding catheter advances and to be arranged on second, seal wire (guidewire) and inner conduit in the interior lumen of inner conduit.Then, seal wire is released the far-end intravasation of guiding catheter, be positioned at endovascular pathological changes point up to the distal portions of the seal wire that carries compressed stent.In case compressed stent is positioned at lesions, just can release and expandable stent so that its support blood vessels.
Summary of the invention
Each side of the present invention comprise a kind of in blood vessel the system and method for unfolding stopper (occluding device).Stopper can be used for remaking endovascular aneurysm, for example, remakes through neck reconstruction or sacculus.Stopper can be used for forming plugging material is remained on the barrier (barrier) in the aneurysm; Material so that toilet is introduced is not overflowed in aneurysm; For example well-known bung flange of wherein said plugging material or viscous fluid, for example " liquid embolizing agent in the novel vascular " (" ONYX ") of Microtherapeutics company.During launching, the length that also can regulate stopper in response to the friction that between stopper and conduit inner surface, is produced.When this situation occurs, can change the length of run and the girth of stopper as required by the doctor who undergos surgery.
One side of the present invention comprises a kind of system that is used to support with unfolding stopper.This system comprises guiding sheath and the assembly that is used to carry stopper.Said assembly comprises the elongated flexible member; Said flexible member has the retaining member (proximally positioned retaining member) of stopper retaining member (occluding device retaining member), near-end setting; And supporter (support); Wherein said stopper retaining member is used to hold first end of stopper; The retaining member of said near-end setting is used to mesh second end of stopper, and above support surrounds the part of elongated flexible member, and stopper can be positioned on this supporter.
Another aspect of the present invention comprises a kind of system that is used to support with unfolding stopper.This system comprises the assembly that is used to carry stopper.Said assembly comprises elongate member; Said elongate member comprises flexible distal tip part, retaining member and supporter; Wherein said retaining member is used to hold first end of stopper, and above support surrounds the part of elongated flexible member to be used to support stopper.
Further aspect of the present invention comprises a kind of in blood vessel, the introducing and the method for unfolding stopper.The method comprises step: the elongated shape sheath that will comprise the guiding sheath that carries the seal wire assembly is introduced conduit, and the seal wire assembly is released sheath entering conduit.This method also comprises step: end of conduit is positioned proximate to aneurysm, the part of seal wire assembly released conduit, and the part of rotation seal wire assembly, the unfolding stopper in the aneurysm zone simultaneously.
Therefore; First aspect; The invention provides a kind of system that is used to support with unfolding stopper, said system comprises guiding sheath and the assembly that is used to carry said stopper, and said assembly comprises the elongated flexible member; Said elongated flexible member has the retaining member of stopper retaining member, near-end setting; And supporter, said stopper retaining member is used to hold first end of said stopper, and the retaining member of said near-end setting is used to mesh second end of said stopper; Above support extends and has the outer surface of the inner surface that is used to mesh said stopper along the part of said elongated flexible member, and said stopper is movably with respect to above support.
In the said system of first aspect, said elongated flexible member can comprise the seal wire with flexible not damaged top.Said seal wire can be with respect to said guiding sheath movably.Wherein, said seal wire can have the section of at least two different-diameters.Said seal wire also can have the section of different curvature.
In the said system of first aspect, above support can surround the part of said elongated flexible member.
In the said system of first aspect, the retaining member of said near-end setting can comprise biasing member, and when said stopper was positioned on the above support, said biasing member was pushed said stopper to the far-end of said flexible member.
In the said system of first aspect, the retaining member of said near-end setting can comprise the part of said elongated flexible member.
In the said system of first aspect, said stopper retaining member can comprise the inside opening of said first end that is used to hold said stopper.
In the said system of first aspect, said stopper retaining member can comprise the bung flange spring.
The said system of first aspect also can comprise conduit, and said assembly and said stopper can be positioned in the said conduit.
In the said system of first aspect, above support can comprise the elongated shape bung flange that is provided with around said elongated flexible member.
In the said system of first aspect, said elongate member can comprise flexible guidewire, and said flexible guidewire is rotatable with respect to said guiding sheath and said stopper.
In the said system of first aspect, said stopper retaining member can have outer surface, and the said outer surface of said stopper retaining member extends far than the outer surface of above support from the outer surface of said elongate member.
In the said system of first aspect, said stopper retaining member can comprise the part of said first end that is used to protect said stopper.
Second aspect; The invention provides a kind of system that is used to support with unfolding stopper; Said system comprises the assembly that is used to carry said stopper; Said assembly comprises elongate member, and said elongate member comprises flexible distal tip part, retaining member and supporter, and said retaining member has the part of first end that is used to hold and keep said stopper; The outer surface of said stopper is extended and be formed for meshing and supporting with respect to said elongate member to the part of the said elongated flexible member in above support edge, makes that said stopper is movably with respect to above support.
In the said system of second aspect, said retaining member can have than the outer surface of above support and extends farther outer surface from the outer surface of said elongate member.
The said system of second aspect also can comprise the guiding sheath that is used to carry said assembly.
In the said system of second aspect, said elongate member can comprise flexible guidewire.Wherein, said seal wire can have at least two sections with different diameters.Said seal wire also can have the section of different curvature.
In the said system of second aspect, said distal tip part can comprise undamaged top.
In the said system of second aspect, said retaining member can comprise the inside recess that is used for before launching said stopper, holding and keeping said first end of said stopper.
In the said system of second aspect, said retaining member can comprise the bung flange spring.
The said system of second aspect also can comprise second retaining member that separates with first retaining member, pushes said first retaining member to the part that is used for meshing stopper and with said stopper.
The said system of second aspect also can comprise conduit, and said assembly and said stopper can be positioned in the said conduit.Wherein, said elongate member can comprise flexible guidewire, and said flexible guidewire is rotatable with respect to said conduit and said stopper.
In the said system of second aspect, above support can comprise flexible bung flange, and said flexible bung flange extends and surround the part of said elongate member on the part of said elongate member.
In the said system of second aspect, said retaining member can comprise the part of said first end that is used to protect said stopper.
In addition, the present invention also provides a kind of and has been used in blood vessel introducing and the method for unfolding stopper, and said method comprises:
To comprise the elongated shape sheath introducing conduit of guiding sheath with the seal wire assembly;
Said seal wire assembly is released said sheath and pushed said conduit;
The end of said conduit is positioned to contiguous aneurysm;
At least a portion of said seal wire assembly is released said conduit;
Rotate the part of said seal wire assembly, launch said stopper at the aneurysm place simultaneously.
Said method also can comprise the step of removing said seal wire assembly in the said conduit.
Said method also can comprise the step of removing said conduit in the blood vessel.
Said method also can be included in launches the step that said stopper is confirmed the position of said stopper before.
Said method also can comprise when launching said stopper, between the inner surface of said conduit and said stopper, forms friction.
In said method, the said step of rotating said seal wire assembly can comprise the step that the end with said stopper and retaining member separates.
Description of drawings
Fig. 1 is stopper conveying assembly and the cross section of stopper according to an aspect of the present invention;
Fig. 2 has showed conduit that Fig. 1 showed and guiding sheath;
Fig. 3 is that the part that Fig. 2 guides sheath is cut away view, has carried the seal wire assembly that stopper is housed;
Fig. 4 is the cross section of the seal wire assembly showed of Fig. 3;
Fig. 5 is the sketch map of the seal wire assembly of Fig. 4;
Fig. 6 is second sketch map of the seal wire assembly of Fig. 4;
Fig. 7 has showed the part of stopper with the seal wire assembly that is arranged on the conduit outside, has showed also how the near-end of stopper begins to launch in vascular;
Fig. 8 has showed the step of unfolding stopper method;
Fig. 9 has showed the expansion of stopper according to an aspect of the present invention;
Figure 10 is the sketch map of seal wire assembly according to another embodiment of the invention; And
Figure 11 is the sketch map of the unfolded stopper after being launched by Figure 10 seal wire assembly.
The specific embodiment
Described the stopper conveying assembly with little cross section part here, it is a high flexibility.Fig. 1 has showed guiding sheath 10 according to an aspect of the present invention, and this guiding sheath 10 holds and loads stopper 100, and stopper 100 is transported to flexible micro 1 is positioned in individual's the vascular system being used to.Stopper 100 can comprise disclosed those embodiments in the co-pending U.S. patent application of submitting on May 25th, 2005 (Atty.DocketNo.006258.00010) that is entitled as " flexible vascular stopper " (" Flexible Vascular Occluding Device "), and the full content of this patent is incorporated herein by reference at this especially.
The size and the profile of the far-end 12 of guiding sheath 10 formed in the jack (hub) 2 that can be contained in microtubular 1, like what Fig. 1 and 2 showed.Jack 2 can be arranged on the near-end of microtubular 1 or be arranged on another position of opening along the intervals of lengths of microtubular 1.Microtubular 1 can be can pass patient's vascular system to introduce and propulsive any known microtubular.In embodiments, microtubular has 0.047 inch internal diameter or littler internal diameter.In another embodiment, microtubular have about 0.027 inch to about 0.021 inch internal diameter.In alternative embodiment, microtubular can have about 0.025 inch internal diameter.Yet, can be contemplated that conduit 1 can have greater than 0.047 inch or less than 0.021 inch internal diameter.Guiding after sheath 10 is positioned in the catheter hub 2, can stopper 100 be pushed microtubular 1 from guiding sheath 10, to prepare unfolding stopper 100 in patient's vascular system.
Microtubular 1 can have and is positioned at contiguous jack 2 or is positioned at least one the fluid intake (fluid introduction port) 6 along another position of its length.Mouthfuls 6 preferably are communicated with the far-end fluid of microtubular 1, so that for example the fluid of saline etc. can pass microtubular 1 to be used to wash away in the microtubular 1 and for example to be arranged on air or the fragment in any utensils such as seal wire in the microtubular 1 before microtubular 1 inserts vascular system.Mouth 6 can also be used in vascular system, carrying medicine or fluid as required.
Fig. 3 has showed guiding sheath 10, the elongated flexible delivery guidewire assembly 20 and the stopper 100 that can in guiding sheath 10, move.Like what shown, seal wire assembly 20 and also do not introduce microtubular 1 by the stopper 100 that seal wire assembly 20 carries.But, like what showed, seal wire assembly 20 and by the stopper 100 that seal wire assembly 20 carries still be positioned at the guiding sheath 10.Guiding sheath 10 can be processed by various thermoplastics, for example PTFE, FEP, HDPE, PEEK etc., these materials can be randomly for example PVP or some other texs are embedded on the inner surface of sheath or on the neighbouring surface with water wetted material.In addition, according to desired result, arbitrary surface all can scribble various combinations of different materials.
Guiding sheath 10 can comprise scavenge port (drainage port) or Purge holes (purge hole) (not shown), and these scavenge ports or Purge holes are formed near the wall the zone that covers stopper 100.Can have singlely or a plurality of, for example three are formed into the holes of guiding in the sheath 10.These Purge holes make such as the fluid of saline etc. can work as before location guiding sheath 10 contact with catheter hub 2, purify sheath for example when removing air entrapment or fragment easily from guiding effusion between sheath 10 and the seal wire assembly 20.
Like what Fig. 4 showed, seal wire assembly 20 comprises elongated flexible guidewire 21.It is crooked with consistent with the curvature of vascular system that the flexibility of seal wire 21 allows seal wire assembly 20 to come according to the position movement requirement of stopper 100 in vascular system.Seal wire 21 can be processed and can be had solid cross section by traditional guidewire material.Alternatively, seal wire 21 can be formed by hypotube (hypotube).In each embodiment, seal wire 21 has about 0.010 inch diameter D to about 0.020 inch scope 5In embodiments, the maximum gauge of seal wire 21 is about 0.016 inch.The material that is used for seal wire 21 can be any known guidewire material, comprises superelastic metals, for example Nitinol.Alternatively, seal wire 21 can be by forming such as stainless metal.The length L of seal wire 4Can be that about 125cm is to about 190cm.In embodiments, length L 4About 175cm.
Seal wire assembly 20 can have the curvature of same degree along its whole length.In alternative embodiment, seal wire assembly 20 can have and has vertical section of flexion/stiffness in various degree.The curvature in various degree of seal wire assembly 20 can be through using material different and/or thickness to form in the different vertically sections of seal wire 21.In another embodiment, the curvature of seal wire 21 can be controlled by otch (cut) (not shown) at the interval that in delivery guidewire 21, forms.These otch can be vertical and/or circumferentially spaced-apart.Otch can be precisely defined in the delivery guidewire 21.The different sections of delivery guidewire 21 can comprise that the otch that forms with different spacing and different depth provides not commensurability curvature and rigidity to give these segments of different.In above any embodiment, seal wire assembly 20 and 21 pairs of Torque sensors that are applied to seal wire assembly 20 by the operator of seal wire.As following described, the moment of torsion that is applied to seal wire assembly 20 through seal wire 21 can be used to discharge stopper 100 from seal wire assembly 20.
Can be controlled in the size and dimension of the otch that forms in the delivery guidewire 21 so that the more or less flexibility of amount is provided.Or not the degree of depth or the overall shape of otch because otch can in width range, change, do not influence the torsional strength of delivery guidewire 21 so can optionally change the flexibility of delivery guidewire 21.Like this, just optionally and independently change the flexibility and the torsional strength of delivery guidewire 21.
Advantageously, vertically the otch of vicinity is spent so that distortion laterally and vertically to be provided the mutual on every side rotation about 90 that can center on delivery guidewire 21.Yet otch also can be positioned at preposition so that the distortion of selecting the superior of one or more desired directions to be provided.Certainly, otch also can at random form to allow non-preferentially bending (curvature) comparably in all directions or plane.In one embodiment, this can realize through circumferentially spaced otch.
Flexible delivery guidewire 21 can comprise having the same degree or any amount of section of curvature in various degree.For example, flexible delivery guidewire 21 can comprise two or more sections.In the embodiment that Fig. 4 showed, flexible delivery guidewire 21 comprises three sections with different-diameter.Each section can have about 0.005 inch to about 0.025 inch diameter.In embodiments, the diameter of one or more section can be about 0.010 inch to about 0.020 inch.First section 22 comprises the near-end 23 that is positioned at stopper 100 opposite location.First section 22 can have fixed thickness along its length.Alternatively, first section 22 can have the only thickness (diameter) of the convergent of a part along its whole length or its length.In the embodiment of convergent, the thickness of first section 22 (diameter) second, the direction of transition zone 24 reduces.Have those embodiments of circular cross section for seal wire 21, thickness is the diameter of section.
The second, transition zone 24 extends between first section 22 and the 3rd, distal section 26.Second section 24 on thickness from the major diameter of first section 22 taper to the 3rd section 26 than minor diameter.The same with first section 22, second section 24 can be along only a part of convergent of its whole length or its length.
Compare with other sections 22,24 of delivery guidewire 21, the 3rd section 26 has less thickness.The 3rd section 26 extends second section 24 that leaves the convergent that carries stopper 100.The 3rd section 26 can taper to the far-end 27 of delivery guidewire 21 along its whole length from second section 24.Alternatively, the 3rd section 26 can have fixed diameter or only along a part of convergent of its length.In such embodiment, the tapered portion of the 3rd section 26 can be from second section 24 or from extending to the far-end 27 position spaced point with delivery guidewire 21 with second section, 24 position spaced point.Although describe and showed three sections of delivery guidewire 21, delivery guidewire 21 can comprise the section more than three.In addition, each in these sections can be along its whole length or is only gone up convergent along the part of its length at its thickness (diameter).In disclosed any embodiment, delivery guidewire 21 can be formed by marmem such as Nitinol.
Top 28 and flexible tip coil 29 are fixed to the far-end 27 of delivery guidewire 21, like what Figure 4 and 5 showed.Top 28 can comprise successive end cap or end cap, and like what shown in the figure, said end cap or end cap firmly hold the far-end of tip coil 29.Tip coil 29 provides curvature control for the distal portions of delivery guidewire 21.Yet in embodiments, top 28 can not have bung flange 29.Top 28 has not endermic, atraumatic end face.In the embodiment of being showed, top 28 has rounded face.In alternate embodiment, top 28 can have other not endermic shapes, and this shape can not injure the blood vessel that it imports.Like what Fig. 4 showed, top 28 comprises shell (housing) 45, and said shell 45 firmly is contained in the far-end of seal wire 21 in the opening 46 in the inner surface of shell 45.Can seal wire 21 be fixed in the opening by any any means known.
As shown in Figure 4, the part that tip coil 29 is surrounded seal wire 21.Tip coil 29 is flexible, and when blood vessel advanced, tip coil 29 was consistent with the intravital blood vessel of patient path and go along patient intravital blood vessel path with convenient top 28, and seal wire 21 bendings are with the zigzag path of guard system along the pulse and go.Tip coil 29 28 extends back from the top in the direction of near-end 23, like what shown.
Top 28 and bung flange 29 have about 0.010 inch to about 0.018 inch D outer diameter 1In embodiments, the D outer diameter of top 28 and bung flange 29 1About 0.014 inch.Top 28 also has the length L of about 0.1cm to about 3.0cm with bung flange 29 1In embodiments, they have the total length L of about 1.5cm 1
At far-end 24 places of protection bung flange (protective coil) 35, the near-end 30 of tip coil 29 was contained in the shell 32, like what Fig. 1 and Fig. 4 showed.Shell 32 and protection bung flange 35 have about 0.018 inch to about 0.038 inch D outer diameter 2In embodiments, the D outer diameter of shell 32 and protection bung flange 35 2About 0.024 inch.Shell 32 has the length L of about 0.05cm to about 0.2cm with protection bung flange 35 2In embodiments, their total length L 2About 0.15cm.
Shell 32 has not endermic, atraumatic shape.For example, like what Fig. 5 showed, shell 32 has round end profile (blunt profile) in fact.And the size of shell 32 can form can the open/support blood vessel when it passes blood vessel.In addition, shell 32 can comprise angled side walls, and the size of this sidewall forms and just separates the inner surface of guiding sheath 10.
Shell 32 forms far-end retaining member (retaining member) with protection bung flange 35; Before conveying and the unfolding stopper 100, this retaining member is kept the position of stopper 100 on flexible guidewire assembly 20 and is helped to keep stopper 100 to be in compressive state in the blood vessel of vascular system.Protection bung flange 35 extends from shell 32 in the direction of the near-end 23 of delivery guidewire 21, like what Fig. 4 showed.Protection bung flange 35 is fixed to shell 32 with any known mode.In the first embodiment, protection bung flange 35 can be fixed to the outer surface of shell 32.In alternative embodiment, protection bung flange 35 can be fixed in the opening of shell 32 so that shell 32 surrounds and internally holds the far-end 51 (Fig. 4) of protecting bung flange 35.Shown that like Fig. 3 and 4 far-end 102 of stopper 100 remains in the near-end 52 so that stopper 100 does not launch in be positioned at sheath 10 or microtubular 1 time.
At the near-end of stopper 100, bumper coil (bumper coil) 60 and medicated cap 62 prevent that stopper 100 from the length shifted laterally along seal wire 21 of the direction of near-end 23, seeing Fig. 3.Bumper coil 60 has about 0.018 inch to 0.038 inch D outer diameter with medicated cap 62 4In embodiments, the D outer diameter of bumper coil 60 and medicated cap 62 4About 0.024 inch.The near-end 107 of medicated cap 62 contact stoppers 100 also prevents that stopper 100 from moving away protection bung flange 35 along the length of seal wire 21.Bumper coil 60 can be a form of springs, and it is at the direction contact and the compression cap 62 of protection bung flange 35, thus the bias force of generation opposing stopper 100.This bias force (pressure) helps to keep the far-end 102 of stopper 100 and fixing, the covering relation between the protection bung flange 35.The same with any bung flange that is provided with along delivery guidewire 21, bumper coil 60 can be through soldering, welding, RF welding, gummed and/or other known adhesive to delivery guidewire 21.
In the alternative embodiment that Figure 10 showed, do not use bumper coil 60.Instead, in the time of in stopper 100 is positioned in guiding sheath 10 or microtubular 1, the near-end 107 of stopper 100 is kept in position by one group of spring-loaded arm (claw) 140.The expanded radially of the inner surface of microtubular 1 and guiding sheath 10 restricted arm 140.When the near-end of stopper passes microtubular 1, arm 140 will flick and discharge stopper, like what Figure 11 showed.
In alternative embodiment, can there be bumper coil 60 convergent section that the near-end of stopper 100 is remained on the appropriate location with respect to protection bung flange 35 with medicated cap 62 and through seal wire 21.In such embodiment, the big cross section of this convergent section can be used to stopper 100 remained on the appropriate location and can be used to prevent that stopper 100 from moving in the direction of near-end 23 along the length of delivery guidewire 21.
Like what Fig. 4 showed, seal wire assembly 20 comprises the supporter 70 that is used for stopper 100.In the first embodiment, supporter 70 can comprise the outer surface of delivery guidewire 21, and the size of the outer surface of delivery guidewire 21 forms the inner surface that is contained in seal wire assembly this outer surface contact stopper 100 of 20 last times when stopper 100.In this embodiment, the outer surface of delivery guidewire 21 supports stopper 100 and it is maintained the unfolded state of preparing.In another embodiment, show that like figure supporter 70 comprises mid-coil (mid-coil) 70, it extends towards bumper coil 60 from the position near protection bung flange 35 backward.Mid-coil 70 is extending under the stopper 100, on the delivery guidewire 21, like what Fig. 1 showed.Mid-coil 70 can be extended with one or more section of delivery guidewire 21 jointly.For example, mid-coil 70 can be only extended with second section 24 of delivery guidewire 21 jointly, perhaps mid-coil 70 can be not only along the 3rd section 26 of delivery guidewire 21 but also along the part extension of second section 24 of delivery guidewire 21.
Mid-coil 70 provides outward extending surface for seal wire assembly 20, and the size on the surface of this extension forms the inner surface of contact stopper 100 so that help to support stopper and stopper 100 is maintained the unfolded state of preparing.Other bung flanges of being showed in as described herein and the figure are the same, and the coiling form of mid-coil 70 allows to pass patient's vascular system when advancing when delivery guidewire 21, and mid-coil 70 is with delivery guidewire 21 bendings.Mid-coil 70 provides along the fixed diameter of the length that is covered by stopper 100 of delivery guidewire 21, and the tapering of the delivery guidewire 21 below stopper 100 is irrelevant.Mid-coil 70 allows delivery guidewire 21 convergents, and it can realize that needed flexibility goes with the path of guard system along the pulse like this, and can't damage the support that offers stopper 100.Before stopper 100 launched, mid-coil 70 provided constant support for stopper 100 and irrelevant with the tapering of delivery guidewire 21.The minimum diameter of stopper 100 when compressive state also controlled by the size of mid-coil 70.In addition, can select the diameter of mid-coil 70, comprise not at interval so that before stopper 100 launches, between the inwall of stopper 100 and microtubular 1, set up proper spacing.Mid-coil 70 can also be used to during stopper 100 launches, delivery guidewire 21 being left in stopper 100 biasings.
In arbitrary embodiment, supporter 70 can have about 0.010 inch to about 0.018 inch D outer diameter 3In embodiments, D outer diameter 3About 0.014 inch.Supporter 70 also can have the length L of about 2.0cm to about 30cm 3In embodiments, the length L of supporter 70 3About 7cm.
Stopper 100 also can be arranged on along localized a pair of optional not the passing through on the mid-coil 70 between the radiation label band (radio-opaque marker band) of the length of seal wire assembly 20.Alternatively, protection bung flange 35, bumper coil 60 and/or mid-coil 70 can comprise not radiation label thoroughly.In alternative embodiment, seal wire assembly 20 can include only the single radiation label that do not pass through.The use of not passing through the radiation label makes that seal wire assembly 20 is visible with stopper 100 when in vascular system, placing.Visible technology like this can comprise traditional method, for example radioscopy, radiography, ultrasound investigation, nmr imaging technique etc.
Can and change according to following method and carry and unfolding stopper 100 at the position of aneurysm A.The conveying of stopper 100 comprises introduces vascular system with microtubular 1, arrives the position that requires treatment up to stopper 100.Can use conventional art that microtubular 1 is introduced vascular system, for example on conventional vascular seal wire (not shown), advance or advance simultaneously with the conventional vascular seal wire.The location of microtubular 1 can occur in microtubular 1 and hold before the seal wire assembly 20 or when occurring in microtubular 1 guidewire assembly 20.Can be arranged on the microtubular 1 or be arranged on the microtubular 1 interior radiation label that do not pass through through identification and confirm the position of microtubular 1 in vascular system.
After microtubular 1 is positioned at desirable position, removes seal wire and also will guide the near-end that the far-end of sheath 10 inserts microtubular 1, like what Fig. 1 showed.In embodiments, the jack 2 that passes the proximal end of microtubular 1 is introduced the far-end of guiding sheath 10.In microtubular 1, advance guiding sheath 10, in the distal tip wedging microtubular 1 of guiding sheath 10.In this position, guiding sheath 10 can not further be advanced in microtubular 1.Then, guiding sheath 10 firmly remains on this position, passes guiding sheath 10 simultaneously and advances the delivery guidewire assembly 20 that carries stopper 100, is pushed out guiding sheath 10 up to stopper 100 and gets in the microtubular 1.
Pass microtubular 1 and advance seal wire assembly 20 and stopper 100, up to the far-end of tip coil 29 near microtubular 1.At this point, can confirm the position of microtubular 1 and seal wire assembly 20.Then, seal wire assembly 20 is pushed out microtubular 1 and gets into patient's vascular system so that the near-end 107 of stopper 100 is positioned at outside and contiguous the to be treated zone of the far-end of microtubular 1.The position that on any location point during these steps, can detect stopper 100 is to confirm that stopper 100 will correctly launch and in desirable position.This can realize through using the radiation label that do not pass through described above.
When the far-end 102 of stopper 100 is located in the outside of microtubular 1, near-end 107 will begin to expand in vascular system with the direction that Fig. 7 arrow is shown, far-end 102 keeps being covered by protection bung flange 35 simultaneously.After stopper 100 was in the tram, delivery guidewire 21 rotation (see figure 8)s moved away protection bung flange 35 and launch in vascular system in desirable position up to the far-end 102 of stopper 100.Delivery guidewire 21 can turn clockwise or be rotated counterclockwise with unfolding stopper 100 as required.In embodiments, for example, delivery guidewire 21 can be in rotation between two commentaries on classics and ten are changeed on a direction or the both direction.In another embodiment, can be less than five commentaries on classics through the delivery guidewire 21 that turns clockwise, for example, three forward five to transfers unfolding stopper.After stopper 100 launched, delivery guidewire 21 regracting microtubulars 100 were also removed from human body.
In alternative or other deployment step that Fig. 9 showed, the friction between the inner surface of stopper 100 and microtubular 1 causes the far-end of stopper 100 to be opened in 35 minutes from the protection bung flange.This friction can be through opening stopper 100 and/or forming friction towards the mid-coil 70 of the inner surface of microtubular 1 biasing stopper 100.Friction between microtubular 1 and the stopper 100 helps unfolding stopper 100.Do not opening during launching when stopper 100 and under protection bung flange 35 isolating those situations; Friction between the inner surface of stopper 100 and microtubular 1 will make stopper 100 move away protection bung flange 35, because delivery guidewire 21 moves relative to one another with microtubular 1.Then, delivery guidewire 21 rotations and stopper 100 launch in blood vessel.
Stopper 100 radially expand to voluntarily mild but firm, contact so that after the cervical region of shutoff aneurysm A with the wall of blood vessel, can microtubular 1 be removed in patient's body fully.Alternatively, can other instruments inserted or near drug application treatment position with permission in the appropriate location that microtubular 1 is stayed in the vascular system near the treatment position.
The present invention can use known material.A kind of common material that can be used for stopper 100 and seal wire 21 is a kind of nickel-titanium shape memory alloy Nitinol; This material can be shaped and anneal, and is out of shape at low temperatures, and returns to its original-shape through adding heat energy; For example, when in human body, under body temperature, launching.Not passing through the radiation label can form by not passing through radiative material, comprises metal, for example platinum comprise bismuth or the doped plastics of tungsten to help it is thus clear that.
Apparatus and method described herein are not limited to expansion and the use in vascular system, and can comprise any further therapeutic use.The other treatment position can comprise human body or the zone such as organ body (organ body) etc.Be used for realizing apparatus and method described above of the present invention each modification and be that the variation of conspicuous each side of the present invention all drops in the scope of claim for the technical staff in present technique field.In addition, do not have parts, element or method step to be intended to be exclusively used in the public, and whether be described in the claim irrelevant clearly with parts, element or method step.

Claims (19)

1. system that is used to support with unfolding stopper; Said system comprise sheath be shaped as the assembly that carries said stopper, said assembly comprises the elongated flexible member, said elongated flexible member comprises the stopper retaining member of first end that holds said stopper; Said stopper retaining member comprises the protection bung flange; Said stopper retaining member rotatably is arranged to, and the revolving force of the near-end through being applied to said elongated flexible member makes said flexible member rotate about said sheath around its longitudinal axis; Make the far-end of stopper move away the protection bung flange, and make said stopper from said elongated flexible structural member development.
2. system according to claim 1, wherein, said elongated flexible member comprises the seal wire with flexible not damaged top.
3. system according to claim 2, wherein, said seal wire can vertically move with respect to said sheath.
4. system according to claim 2, wherein, said seal wire has the section of at least two different-diameters.
5. system according to claim 2, wherein, said seal wire has the section of different curvature.
6. system according to claim 1; Wherein, Said stopper retaining member comprises inner recess; Said inner recess is shaped as said the rotatablely moving through said elongated flexible member and launches said first end that said stopper holds and keep before said stopper, and wherein, said stopper retaining member is fixed to said flexible member.
7. system according to claim 1; Also comprise the retaining member that near-end is provided with; The retaining member of said near-end setting is shaped as second end of the said stopper of engagement; Wherein, the retaining member of said near-end setting comprises biasing member, and said biasing member is pushed said stopper to the far-end of said flexible member.
8. system according to claim 7, wherein, the retaining member of said near-end setting comprises the part of said flexible member.
9. system according to claim 1 also comprises conduit, and said assembly and said stopper place said conduit.
10. system according to claim 1, wherein, said stopper retaining member comprises the part of said first end that is shaped as the said stopper of protection.
11. system according to claim 1, wherein, said stopper is a support.
12. system according to claim 11, wherein, said support is the porous support of braiding.
13. system according to claim 11, wherein, said support is an expandable stent voluntarily.
14. system according to claim 1 also comprises supporter, above support extends along the part of said flexible member, and has the outer surface of the inner surface that is shaped as the said stopper of engagement.
15. system according to claim 14, wherein, above support surrounds the part of said flexible member.
16. system according to claim 14, wherein, above support comprises the elongated shape bung flange.
17. system according to claim 14, wherein, said stopper is movably with respect to above support.
18. system according to claim 14, wherein, said stopper retaining member has outer surface, and the said outer surface of said stopper retaining member extends far than the outer surface of above support from the outer surface of said flexible member.
19. system according to claim 1, wherein, said protection bung flange is contained in said first end of said stopper in the inside of said protection bung flange.
CN 201010259695 2005-05-25 2005-05-25 System and method for conveying and unfolding stopper in blood vessel Expired - Fee Related CN101926667B (en)

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EP3102273A1 (en) * 2014-02-03 2016-12-14 Medinol Ltd. Catheter tip assembled with a spring
US9789283B2 (en) 2014-02-03 2017-10-17 Medinol Ltd. Catheter tip assembled with a spring
CN111419299B (en) * 2017-07-13 2021-08-31 先健科技(深圳)有限公司 Plugging device pushing device and conveying system
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