CN102038533A - Microcoil vessel obstruction device with multi-axis secondary configuration - Google Patents

Abstract

The invention relates to a microcoil vessel obstruction device, comprising a microcoil. The microcoil is formed to be in minimum-energy-state secondary configuration by winding. The secondary configuration comprises a plurality of bending sections connected by planes; and each bending section limits a plane with an independent shaft; and for each of the connected bending sections, the adjacent sections are wound in an opposite direction. Therefore, the device in the minimum-energy-state configuration limits the independent shafts, and if the independent shafts are crossed, an angle of less than or equal to 45 degrees is formed between every adjacent shafts.

Description

Little coil angiemphraxis device with multiaxis secondary configuration

Divide an application

Itself is dividing an application for No. 01823773.8 patent application of application number (international application no PCT/US01/50970, international publication number WO03/039376) please.01823773.8 the applying date of number patent application is July 11 calendar year 2001, denomination of invention is " the little coil angiemphraxis device with multiaxis secondary configuration "

The cross reference of related application

Inapplicable.

The research of federal funding or exploitation

Inapplicable.

Technical field

The present invention relates generally to angiemphraxis Apparatus and method for field.More specifically, the present invention relates to form the Apparatus and method for that thromboembolism comes occluding vascular by the target site in blood vessel (as aneurysm).

Background technology

Under a lot of clinical settings, want to obtain blood vessel embolism.For example, blood vessel embolism has been used to control angiorrbagia, blocks the blood supply to tumor, occluding vascular aneurysm, especially intracranial aneurysm.In recent years, be used for the treatment of aneurysmal blood vessel embolism and caused very big attention.Several different form of therapy have been adopted in the prior art.Dormandy for example, people's such as Jr. United States Patent (USP) 4,819,637 has been described a kind of vascular embolization system that utilizes separable balloon, and described balloon is delivered to aneurysm site by endovascular conduit.Balloon is carried in the aneurysm of catheter tip, and owing to solidified liquid (typically being polymer resin or gel) expands with the obstructing arterial tumor in aneurysm.By soft traction on conduit balloon is separated with conduit then.Though the thromboembolism equipment of balloon type can block the aneurysm of a lot of types effectively, solidify the back at solidified liquid and be difficult to its recovery or mobile, unless fill contrast material, be difficult to it is visual.And, also exist balloon in the expansion process to break and too early with the danger of conduit disengaging.

Another kind of mode is directly to the vascular site injecting fluid polymer plug agent that will block.A class I liquid I polymer that uses in the direct injection technology is as rapid polymerization liquid, as cyano-acrylate resin, and isobutyl cyanoacrylate especially, this polymer is delivered to target site with the form of liquid, then in the original place polymerization.Alternatively, used a kind of liquid polymers that from carrier solution, is precipitated out at target site.An example of this class suppository be mixed with bismuth oxide and be dissolved in cellulose acetate polymer in the dimethyl sulfoxide (DMSO).Another kind of suppository is the glycol copolymer that is dissolved among the DMSO.After blood contacted, DMSO just spread apart, and polymer precipitation comes out and quick-hardening becomes to have the embolic mass of aneurysm shape.Other example of the material that adopts in this " direct injection " method is disclosed in following United States Patent (USP): people's such as Paesztor 4,551,132; People's such as Leshehiner 4,795,741; People's such as Ito 5,525,334; With people's such as Greff 5,580,568.

Proved that the agent of direct injection liquid polymer plug is very difficult in practice.For example, to move to contiguous blood vessel from aneurysm be exactly a problem to polymeric material.In addition, a kind of contrast medium of visual needs of embolism materials mixes with it, and embolism materials that selection is mated mutually and contrast medium can cause performance to be affected and be lower than optimum efficiency.And the configuration of accurately controlling the polymerization embolism materials is very difficult, can cause the risk of incorrect placement of this material and/or premature setting.And,, be difficult to it is moved or reclaims in case embolism materials is configured and solidifies.

The method that another kind has prospect is to use thrombosed little coil.Coil can be by biocompatible metals alloy (typically being platinum and tungsten) or suitable polymers manufacturing slightly for this.If adopt the metal manufacturing, coil can be provided to improve thrombosis by polyester fiber.Coil is configured by the microtubular that arrives vascular site.The example of little coil is disclosed in the following United States Patent (USP): people's such as Ritchart 4,994,069; People's such as Guglielmi 5,122,136; People's such as Butler 5,133,731; People's such as Chee 5,226,911; People's such as Chee 5,304,194; 5,312,415 of Palermo; People's such as Phelps 5,382,259; Dormandy, people's such as Jr. 5,382,260; Dormandy, people's such as Jr. 5,476,472; 5,578,074 of Mirigian; 5,582,619 of Ken; 5,624,461 of Mariant; People's such as Mariant 5,639,277; 5,658,308 of Snyder; 5,690,667 of Gia; People's such as McGurk 5,690,671; People's such as Mirigian 5,700,258; People's such as Berenstein 5,718,711; People's such as Taki 5,891,058; People's such as Ken 6,013,084; People's such as Rosenbluth 6,015,424; With people's such as Mariant Des.427,680.

Though little coil component of a lot of prior aries has obtained some successes in treatment has the microaneurysm of narrow relatively neck, but the little coil angiemphraxis device that it has been recognized that the most normal employing is in the aneurysm of wide neck, especially in brain, also do not reach satisfied result.This has caused the development of three-dimensional little coil component, as those at 5,645,558 of the disclosed device of following United States Patent (USP): Horton; People's such as Pham 5,911,731; With 5,957,948 (latter two belong to the device that a class is called as " three-dimensional Guglielmi detachable coil " or " 3D-GDC ' s ") of Mariant.Referring to people such as for example Tan " The Feasibility ofThree-Dimensional Guglielmi Detachable Coil for Embolisation of WideNeck Cerebral ANEURYSMS; " Interventional Neuroradiology, Vol.6, pp.53-57 (June, 2000); Cloft et al., " Use of Three-Dimensional GuglielmiDetachable Coils in the Treatment of Wide-necked Cerebral Aneurysms; " American Journal of Neuroradiology, Vol.21, pp.1312-1314 (August, 2000).

Typical three-dimensional little coil is formed by one section tinsel, and tinsel at first forms the one-level configuration of spiral winding, forms then to belong to secondary configuration a kind of in the multiple 3D shape.The minimum energy state of this type of little coil is its three-dimensional secondary configuration.In the time of in being configured in aneurysm, these devices present 3-d modelling, typically are some spheric configuration, are in or are slightly larger than the minimum energy state of secondary configuration.Because the overall size of these devices when its non-minimum energy state configuration is approximately equal to or less than aneurysmal inside dimension, so do not have thing to limit this device because blood flow power moves in aneurysm or upset.

In some of these three-dimension devices (as people's such as Guglielmi United States Patent (USP) 5,122,136), secondary configuration this as helical form or form some similar type of longitudinal axis.When having the device that can be called as " vertically " secondary configuration when being configured in the aneurysm, these devices form three-dimensional non-minimum energy state configuration, but in case after being configured, they promptly show the trend that is returned to minimum energy state.This causes again because the compressing of " coin stacking " (coin stacking) (that is, getting back to the deuterostrophies configuration), thereby allows aneurysmal heavy logical.

Therefore for a long time need but do not obtain so little coil angiemphraxis device as yet, it has the advantage of little coil component of many prior aries, but can be effectively used to treat the aneurysm of many different size configurations, and especially those have the aneurysm of big neck breadth degree.For such device advantageously, compatible with the little coil delivery mechanism of microtubular during use with existing leading line, and can make with the expense suitable with little coil component of prior art.

Summary of the invention

Briefly, the present invention is a kind of little coil angiemphraxis device, and this device has the minimum energy state secondary configuration that comprises a plurality of bending sections, and each bending section defines a discrete axle, and the device that is in minimum energy state configuration thus defines a plurality of axles.More specifically, each bending section defines a plane and one and the vertical substantially axle in this plane.

In an especially preferred embodiment, the present invention is the little loop construction with minimum energy state secondary configuration of an elongation, and this minimum energy state secondary configuration defines a plurality of interconnected tangently and almost circular coils that define a plurality of discrete axles.In a kind of form of preferred embodiment, described circular basically closing coil is coplane basically, and defines substantially parallel axle.That is to say the basic coplane in plane self that limits by described bending section.In the another kind of form in preferred embodiments, every pair of adjacent coil has formed a low-angle, is not more than about 90 °, preferably is not more than about 45 ° angle thereby their axles have separately formed one between them.

In an alternate embodiment, little loop construction has minimum energy state secondary configuration, this minimum energy state configuration secondary configuration defines the structure of the similar waveform of a vertical array that comprises horizontal alternative open stich, and described open stich defines a plurality of discrete axles.In described preferred embodiment, alternate embodiment can be first kind of form, coil coplane and substantially parallel axes separately basically wherein, perhaps can be second kind of form, wherein every pair of adjacent coil has formed a low-angle, is not more than about 90 °, preferably is not more than about 45 ° angle thereby their axles have separately formed one between them.

In any one embodiment, the size of devices that is in its minimum energy state secondary configuration than this device will dispose wherein the spatial full-size of blood vessel big abundant (preferably greatly at least about 25%).Therefore, in the time of in this device is configured in such as aneurysmal vascular site, the restriction to device in this position causes this device to present the 3-d modelling higher than minimum energy state.Because the minimum energy state of device is than the space of using it therein big (one dimension at least), so the device that is configured is by being limited to be returned to minimum energy state configuration with tight contact of aneurysm wall.Therefore, this device still and aneurysm wall surface on every side be connected, thereby make by moving of causing of blood flow power or upset reduces to minimum.And minimum energy state secondary configuration (configuration that this device is attempted to be returned to) is not the structure that helps " coin stacking ", thereby the degree that compresses that is experienced is reduced to minimum.

The invention provides effective thromboembolism of the blood vessel structure (especially aneurysm) with a variety of shape and size, this will be better understood in detailed description subsequently.When being used for wide carotid aneurysm, especially has advantage.And the present invention can adopt conventional configuration mechanism such as microtubular and leading line to be configured, and this will be described in more detail in bottom.

Description of drawings

Fig. 1 is the perspective view according to little coil angiemphraxis device of the preferred embodiments of the invention;

Fig. 2 is the partial view of the described device of Fig. 1 label 2 specified portions in Fig. 1;

Fig. 3 and 4 is the partial view according to little coil angiemphraxis device of the another kind of form of the preferred embodiments of the invention;

Fig. 5 is the plane graph according to little coil angiemphraxis device of alternate embodiment of the present invention;

Fig. 6 is the front view of the present invention in enter the process that wide carotid aneurysm is configured by microtubular;

Fig. 7 is the perspective view that is used to make the heat treatment fixing device of the preferred embodiments of the invention.

The specific embodiment

At first, shown a kind of little coil angiemphraxis device 10 according to the preferred embodiments of the invention referring to figs. 1 to 4 and 8.Device 10 comprises the tinsel (Fig. 2) of one-level configuration of the formation spiral winding 12 of one section appropriate length.The various alloys that device 10 suitable materials comprised platinum, rhodium, palladium, rhenium, tungsten, gold, silver, tantalum and these metals.Also can adopt other rustless steel of various Surgical Grade.Preferable material comprises platinum/tungsten alloy of being called as platinum 479 (92%Pt, 8%W can be from Sigmund Cohn, of Mount Vernon, NY obtains) and titanium/nickel alloy (as being become the titanium/nickel alloy of " Nitinol ").Another kind of may favourable material be the composite wire that comprises high resiliency metal and highly radiopaque metal.This composite wire also can be resisted permanent deformation.An example of this composite wire is the product that comprises the inner core of nitinol outer layer and pure standard level platinum, can be from Sigmund Cohn, and of Mount Vernon, NY and Anomet Products, of Shrewsbury, MA. obtains.Can adopt the wire diameter of about 0.0125mm to about 0.150mm.

The diameter of little coil 12 typically at about 0.125mm to about 0.625mm scope, be about 0.25mm about 0.40mm extremely for most of neural and vascular applications preferred range.The axial length of little coil 12 can be the random length of about 5mm between about 1000mm, typically is extremely about 400mm of about 20mm.

The one-level of carrying out little coil 12 under tension force is twined.The pitch that amount of tension and one-level are twined has determined the hardness of little coil 12.These parameters can change the little coil that has different hardness along its length to form along the length of little coil 12, and this little coil has advantage in some applications.

Little coil 12 is formed the secondary configuration that comprises a plurality of bending sections, and each bending section defines an axle, thereby little coil 12 defines a plurality of axles.More specifically, each bending section defines a plane and one and the vertical substantially axle in this plane.In the preferred embodiment of Fig. 1 to 4, bending section is interconnection tangently and basic be circular the coil 14a, the 14b that define a plurality of axles 16 that separate.In a kind of form in preferred embodiments, as shown in Figure 1, described almost circular coil 14a, 14b be coplane basically, and defines substantially parallel axle 16.In the another kind of form of preferred embodiment, shown in Fig. 3 and 4, every couple of adjacent coil 14a, 14b has formed a low-angle, is not more than about 90 ° between them, preferably is not more than about 45 ° angle (θ 1, θ 2, θ 3 and θ 4) thereby their axles 16 have separately formed one.

The preferred embodiments of the invention typically comprise pair of end portions coil 14a and at least one intermediate coil 14b.Typically, nearly 4 intermediate coil 14b can be arranged, this depends on by the vascular site of thromboembolism, still also can use nearly 6 or more intermediate coil for very big vascular site.The diameter of intermediate coil approximates the maximum gauge of target vascular site (as aneurysm), and the diameter of end coil 14a is because below with purpose of description and smaller (preferably, little about 1.5mm).

The little coil 12 of one-level forms secondary configuration by heat treatment, and this is well known in the art.For example, annealed one-level coil can stand specified a period of time under degenerate temperature then at first by being arranged in secondary structure on the mandrel that twines or be wound on a shape and sizeable refractory material.For example for platinum 479, annealing temperature is about 500 ℃ to about 1000 ℃, preferred about 670 ℃, keeps cool to room temperature, and ultrasonic cleaning then about 30 to 90 minutes, preferred about 60 minutes.Thereby make permanent synthesizing secondary configuration, this secondary configuration becomes the minimum energy state configuration of little coil 12.

Fig. 7 has shown the heat treatment fixing device 50 that uses in the manufacture process of preferred version of the present invention.Fixing device 50 is made by refractory material, comprises base 52, and this base has the surface that is provided for the mandrel that secondary twines thereon.This mandrel comprises a plurality of surperficial upwardly extending winding pin 54a, 54b from base 52.Example fixation equipment 50 shown in the accompanying drawing has roughly six pins by the hexagon arranged in patterns.There are two ends adjacent one another are to twine pin and four middle pin 54b that twine.There is a pair of fastening bolt 56 to be used for fixing the end of one-level coil 12 at a end near fixing device.

The diameter of end winding pin 54a twines the diameter of pin 54b slightly less than the centre, to reach above-mentioned magnitude relationship.Distance between a pin 54a and 54b slightly larger in diameter than one-level coil 12 is so that only have a circle one-level coil by having the pin of each secondary coil winding.Therefore, each back one circle of secondary coil is stacked on the top of last circle.This has eliminated any straight part of secondary coil, and described straight part can trend towards pushing coil to female tremulous pulse in layoutprocedure.

In the secondary winding process, one-level coil 12 remains under the tension force.Amount of tension can be adjusted with the coil 14a that controls little coil 12, the extent of rebound of 14b.

Little coil 12 carries out that secondary twines so that when twining on the continuous pin of little coil 12 each on fixing device, coil 14a, 14b can reverses direction.This has guaranteed that coil can coin stacking, and in case be configured the back they with regard to random dispersion in whole aneurysm.And in preferred embodiments, each circle twines complete 360 ° before next circle twines.This has guaranteed that each circle is settled fully before little coil 12 reverses direction in aneurysm.Because circle contact completely makes the loop strength maximum, the coil uniformly distributed.

Fig. 5 has shown the little coil angiemphraxis device 20 according to alternate embodiment of the present invention.This embodiment comprises the little coil 22 of one-level, and the little coil of this one-level forms the secondary minimum energy state configuration that limits similar waveform configuration, and the structure of described similar waveform comprises the laterally alternative vertical array that defines the open stich 24 of a plurality of minutes vertical shafts.As in preferred embodiments, alternate embodiment can be first kind of form, wherein coil 24 basic coplanes and axle 26 separately are substantially parallel, perhaps can be second kind of form, wherein every pair of adjacent coil 24 has formed a low-angle, is not more than about 90 °, preferably is not more than about 45 ° angle thereby their axles 26 have separately formed one between them.Material, size and the method preferred embodiment with above-mentioned aspect all material of making this alternate embodiment is similar.

Fig. 6 has shown the method for the present invention that adopts.In use, the near-end of little coil 12 (or 22) is connected with the far-end of leading line or microtubular (not having to show).Can be by any connection the in many modes as known in the art, as following United States Patent (USP) illustrated, the disclosure that comprises these patents here clearly for your guidance: people's such as Geremia 5,108,407; People's such as Guglielmi 5,122,136; 5,234,437 of Sepetka; 5,261,916 of Engelson; Twyford, people's such as Jr. 5,304,195; 5,312,415 of Palermo; People's such as Pham 5,423,829; 5,522,836 of Palermo; People's such as Northrup 5,645,564; 5,725,546 of Samson; 5,800,453 of Gia; People's such as Sepetka 5,814,062; People's such as Lee 5,911,737; People's such as Saadat 5,989,242; People's such as Jacobsen 6,022,369; People's such as Diaz 6,063,100; People's such as Lulo 6,068,644; With people's such as Lee 6,102,933.

Make target vascular site visual by well-known usual manner in this area.Target vascular site can be the aneurysm 40 that makes female tremulous pulse 42 bifurcateds.Aneurysm 40 has a dome 44 that links to each other with bifurcated artery by neck 46.Conduit 30 passes through in blood vessel, up to the dome 44 that enters aneurysm 40 via neck 46.By means of leading line or microtubular little coil 12 is passed through conduit 30, enter the dome 44 of aneurysm 40 up to little coil 12.

The small-sized end coil 14a that is positioned at little coil 12 far-ends at first enters aneurysm.This helps the proper arrangement of first coil, because less size remains in the aneurysmal neck 46 first coil, avoids female tremulous pulse 42.

Intermediate coil 14b enters aneurysm then.Because their size is fit to aneurysm, can launch reposefully with the minimized friction freedom against aneurysm wall.Because the secondary configuration of little coil 12 is coplane basically, all intermediate coils apply power to the wall of aneurysm dome 44, thereby have improved little coil because the resistance that blood pulses flows and is moved.

When little coil 12 entered aneurysm, it attempted to present its secondary configuration.Yet because it is bigger than aneurysm to be in little coil of secondary configuration, it is restricted to the deployed configuration that trend is filled aneurysm internal volume.In this deployed configuration, little coil is in than the abundant big energy state of its minimum energy state.Therefore, when this device disposes in such as aneurysmal vascular site, cause this device to present the 3-d modelling higher than minimum energy state to the restriction of device in this position.Because the minimum energy state of device is than the space of using it therein big (one dimension at least), the device that is configured is by being limited to be returned to minimum energy state configuration with tight contact of aneurysm wall.Therefore, this device still is connected with on every side aneurysm wall surface, thereby makes by moving of causing of blood flow power or upset reduces to minimum.And minimum energy state secondary configuration (configuration that this device is attempted to be returned to) is not the configuration that helps " coin stacking ", thereby the degree that compresses that is stood is reduced to minimum.

The small-sized end coil 14a that is positioned at little coil 12 near-ends enters aneurysm at last.After little coil is disposed fully, by any suitable method well-known in the art it is controllably separated with leading line, thereby allow to reclaim microtubular or leading line, little coil is stayed suitable place with the thromboembolism aneurysm.After separation, proximal coil 14a curls and enters the neck 46 of aneurysm 40, avoids female tremulous pulse 42.

Like this, the present invention has shown several advantages of the three-dimensional little coil that is better than prior art.For example, because the existence that passes across the coil of neck has increased the covering of aneurysm neck, and any part of device is invaded the probability of female tremulous pulse and is reduced.The secondary coil configuration also provides configuration more stably, in case after being configured, device just shows the more on the whole resistance that coil is compressed, thereby has improved the positional stability of the blood flow that faces pulsation.This stability reaches by total friction lower between device and aneurysm wall.And coil allows device to keep complicated shape in aneurysm, improved thromboembolism at aneurysm random distribution everywhere.

Although this paper has described the preferred embodiments of the invention and alternate embodiment, those skilled in the relevant art will understand their many variations and modification.For example, can find, other secondary configuration that is different from those secondary configuration as herein described can reach the significant advantage of the present invention that most of (if not all) is used for typical aneurysm treatment, or be proved to be especially favourable in concrete clinical practice.Also have, for concrete application, size also may be with disclosed herein different, advantageously to be employed with material.These and other variation and modification be to be regarded as be within the spirit and scope of the invention, as subsequently claims limited.

Claims (21)

1. little coil angiemphraxis device, described device comprises the little coil that forms minimum energy state secondary configuration by winding, this secondary configuration comprises the crooked close segments that a plurality of planes connect, each crooked close segments defines a plane with branch vertical shaft, wherein, for each the crooked close segments in the crooked close segments of described a plurality of connections, its adjacent crooked close segments is wound in the opposite direction, the described device that is in minimum energy state configuration thus defines a plurality of minutes vertical shafts, if and described a plurality of minutes vertical shafts are crossing, then described a plurality of minutes vertical shafts just form between adjacent shaft and are no more than 45 ° angle.

2. device as claimed in claim 1, wherein, each described bending section defines a plane and perpendicular to this planar axle.

3. device as claimed in claim 1, wherein, described a plurality of axles are parallel.

4. device as claimed in claim 1, wherein, described bending section is tangentially interconnective closed loop each other.

5. device as claimed in claim 1, wherein, described bending section is the waveform open loop.

6. device as claimed in claim 1, wherein, described bending section has formed the closed loop of tangential contact each other.

7. angiemphraxis device, described device comprises the little coil that forms minimum energy state secondary configuration by winding, this secondary configuration comprises a plurality of tangentially interconnective planar rondure closed hoops, each planar rondure closed hoop defines a plane and perpendicular to this planar minute vertical shaft, if the axle of adjacent planar circular closure ring intersects thus, then described axle just forms and is no more than 45 ° angle, and wherein, adjacent planar circular closure ring is wound in the opposite direction.

8. device as claimed in claim 7, wherein, the axle of described ring is parallel.

9. device as claimed in claim 7, wherein, described little coil is formed by composite wire.

10. device as claimed in claim 9, wherein, described composite wire comprises radiopaque metal and high resiliency metal.

11. angiemphraxis device, the little coil part that comprises the elongation that forms minimum energy state configuration, wherein at least a portion of this element presents the waveform configuration, this waveform configuration comprises vertical array of open section, wherein, alternative section horizontal expansion in the opposite direction, and wherein, face of each paragraph qualification, independent branch vertical shaft is substantially perpendicular to this plane.

12. device as claimed in claim 11, wherein, described section comprises ring.

13. device as claimed in claim 11, wherein, described little coil part forms minimum energy state configuration, and wherein, described whole little coil part presents the waveform configuration.

14. device as claimed in claim 11, wherein, described little coil part forms minimum energy state configuration, and is small-sized at the end ring of the extremity office of described little coil part with respect to other ring of this little coil part.

15. device as claimed in claim 11, wherein, described little coil part has near-end, and this near-end and delivery apparatus are separable.

16. device as claimed in claim 11, wherein, described ring is coplanar, and described ring axle separately is parallel.

17. device as claimed in claim 11, wherein, every pair of adjacent ring forms little angle.

18. device as claimed in claim 17, wherein, formed angle is no more than 90 °.

19. device as claimed in claim 18, wherein, formed angle is no more than 45 °.

20. device as claimed in claim 11, wherein, described ring is nonoverlapping.

21. device as claimed in claim 11, wherein, described little coil part is for forming little coil of the lax configuration of minimum energy state.

Images